FDA releases March 2016 510(k) clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD March 2016

TOTAL 510(k)s THIS PERIOD 279
TOTAL WITH SUMMARIES 265
TOTAL WITH STATEMENTS 14

DEVICE: QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument
ORION DIAGNOSTICA OY 510(k) NO: K142993(Traditional)
ATTN: ANJA KONTIO PHONE NO : 358 509665917
KIVIHARJUNTIE 11 4B SE DECISION MADE: 10-MAR-16
OULU FI 90220 510(k) STATEMENT

DEVICE: Flight 60 Ventilator
FLIGHT MEDICAL INNOVATIONS LTD. 510(k) NO: K143035(Traditional)
ATTN: Yanir Shaked PHONE NO : 972 8 9235111
13 HAMELACHA STREET NORTH INDUSTRISE DECISION MADE: 30-MAR-16
LOD IL 71520 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QbCheck
QBTECH AB 510(k) NO: K143468(Traditional)
ATTN: Hans Bostrom PHONE NO : 46 706 339209
Kungsgatan 29 SE DECISION MADE: 22-MAR-16
Stockholm SE 11156 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: xevonta dialyzer
B. Braun Avitum AG 510(k) NO: K143482(Traditional)
ATTN: Giuliana Gavioli PH...

Source: Mass Device - April 6, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news