The following data is part of a premarket notification filed by Matrix Medica, Inc. with the FDA for Centurion(tm) Mixer.
Device ID | K884879 |
510k Number | K884879 |
Device Name: | CENTURION(TM) MIXER |
Classification | Gas-machine, Anesthesia |
Applicant | MATRIX MEDICA, INC. 145 MID COUNTY DR. Orchard Park, NY |
Contact | Wynne, P.e. |
Correspondent | Wynne, P.e. MATRIX MEDICA, INC. 145 MID COUNTY DR. Orchard Park, NY |
Product Code | BSZ |
CFR Regulation Number | 868.5160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-11-21 |
Decision Date | 1989-02-09 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00816711020417 | K884879 | 000 |
00816711023913 | K884879 | 000 |
00816711023906 | K884879 | 000 |
00816711023890 | K884879 | 000 |
00816711023883 | K884879 | 000 |
00816711023876 | K884879 | 000 |
00816711023869 | K884879 | 000 |
00816711023852 | K884879 | 000 |
00816711023845 | K884879 | 000 |
00816711023838 | K884879 | 000 |
00816711023821 | K884879 | 000 |
00816711023920 | K884879 | 000 |
00816711023937 | K884879 | 000 |
00816711020196 | K884879 | 000 |
00816711020189 | K884879 | 000 |
00816711020172 | K884879 | 000 |
00816711020165 | K884879 | 000 |
00816711020158 | K884879 | 000 |
00816711020141 | K884879 | 000 |
00816711020134 | K884879 | 000 |
00816711020127 | K884879 | 000 |
00816711020110 | K884879 | 000 |
00816711020103 | K884879 | 000 |
00816711024439 | K884879 | 000 |