FDA releases February 2016 510(k) clearances

February 2016 510(k) Clearances
510(k) summaries or 510(k) statements for final decisions rendered during the period February 2016.
TOTAL 510(k)s THIS PERIOD 224
TOTAL WITH SUMMARIES 213
TOTAL WITH STATEMENTS 11
February 2016 510(k) Clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD February 2016
DEVICE: ANI Monitor
MDOLORIS MEDICAL SYSTEMS SAS 510(k) NO: K142969(Traditional)
ATTN: MATHILDE COLLET PHONE NO : 011 333 62092081
6, RUE DU PR LAGUESSE SE DECISION MADE: 23-FEB-16
LILLE FR 59037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DBSWIN and VistaEasy Imaging Software
Durr Dental AG 510(k) NO: K143290(Traditional)
ATTN: Oliver Lange PHONE NO : 49 07142 7050
Hopfigheimer Strasse 17 SE DECISION MADE: 18-FEB-16
Bietigheim-Bissingen DE D-74321 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MINIARS SCREWS
OVERMED SRL. 510(k) NO: K143596(Traditional)
ATTN: DAVIDE PIZZAMIGLIO PHONE NO : 39 02 45712515
VIA LUCANIA 23 BUCCINASCO SE DECISION MADE: 05-FEB-16
MILAN IT 20090 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AnapnoGuard 100 Respiratory Guard System
HOSPITECH RESPIRATION LTD. 510(k) NO: K150157(Traditional)
ATTN: Yoram Levy PHONE NO : 972 3 9191648
20 HAMAGSHIMIM ST. KIRYAT MATALON SE DECISION MADE: 16-FEB-16
PETACH TIKVA IL 49348 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pain Therapy System, Model PTS-II
COUNTER SCIENTIFIC DEVELOPMENT (GZ510(k) NO: K150277(Traditional)
ATTN: Eagle Eagle PHONE NO : 86 20 38289980
2ND &3RD FLOOR, BLD. 6, DA...

Source: Mass Device - April 5, 2016 Category: Medical Equipment Authors: MassDevice Tags: 510(k) Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news