The following data is part of a premarket notification filed by Bio Clinic Co. with the FDA for American Power Conversions, Back-ups 600.
Device ID | K930791 |
510k Number | K930791 |
Device Name: | AMERICAN POWER CONVERSIONS, BACK-UPS 600 |
Classification | Syringe, Piston |
Applicant | BIO CLINIC CO. 4083 E. AIRPORT DR. Ontario, CA 91761 |
Contact | Greg Godfrey |
Correspondent | Greg Godfrey BIO CLINIC CO. 4083 E. AIRPORT DR. Ontario, CA 91761 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-02-16 |
Decision Date | 1993-08-06 |