FDA releases May 2016 510(k) clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD May 2016 TOTAL 510(k)s THIS PERIOD 213 TOTAL WITH SUMMARIES 205 TOTAL WITH STATEMENTS 8 May 2016 510(k) Clearances SHARE TWEET LINKEDIN PIN IT EMAIL PRINT 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD May 2016 DEVICE: O-PEP PARI RESPIRATORY EQUIPMENT, INC. 510(k) NO: K150044(Traditional) ATTN: Michael Judge PHONE NO : 1 804 2537274 2412 PARI Way SE DECISION MADE: 27-MAY-16 Midlothian VA 23112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ERBE ESU Model VIO dV with Accessories ERBE ELEKTROMEDIZIN GMBH 510(k) NO: K150364(Traditional) ATTN: Axel Retzlaff PHONE NO : 49 7071 70755349 WALDHOERNLESTRASSE, 17 SE DECISION MADE: 05-MAY-16 TUEBINGEN DE 72072 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Filbloc ASSUT EUROPE 510(k) NO: K150553(Traditional) ATTN: GLORIA AGGIO PHONE NO : 39 06 72677348 ZONA INDUSTRIALE SE DECISION MADE: 19-MAY-16 MAGLIANO DEI MARSI IT 1-67062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PINPOINT Endoscopic Fluorescence Imaging System NOVADAQ TECHNOLOGIES, INC. 510(k) NO: K15095...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news