The following data is part of a premarket notification filed by Ametek/thermox Instruments Division with the FDA for Moxus Or Ocm-1 Oxygen Uptake System.
Device ID | K874663 |
510k Number | K874663 |
Device Name: | MOXUS OR OCM-1 OXYGEN UPTAKE SYSTEM |
Classification | Computer, Oxygen-uptake |
Applicant | AMETEK/THERMOX INSTRUMENTS DIVISION 150 FREEPORT RD. Pittsburgh, PA 15238 |
Contact | Richard W Wanek |
Correspondent | Richard W Wanek AMETEK/THERMOX INSTRUMENTS DIVISION 150 FREEPORT RD. Pittsburgh, PA 15238 |
Product Code | BZL |
CFR Regulation Number | 868.1730 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-11-13 |
Decision Date | 1988-05-31 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B9671503000 | K874663 | 000 |