The following data is part of a premarket notification filed by Critichem, Inc. with the FDA for Critichem Continuous Blood Gas Montitor, Cvgm-1000.
| Device ID | K861277 |
| 510k Number | K861277 |
| Device Name: | CRITICHEM CONTINUOUS BLOOD GAS MONTITOR, CVGM-1000 |
| Classification | Monitor, Blood-gas, On-line, Cardiopulmonary Bypass |
| Applicant | CRITICHEM, INC. 49 SINDLE AVE. Little Falls, NJ 07424 |
| Contact | Christopher Acker |
| Correspondent | Christopher Acker CRITICHEM, INC. 49 SINDLE AVE. Little Falls, NJ 07424 |
| Product Code | DRY |
| CFR Regulation Number | 870.4330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-07 |
| Decision Date | 1986-06-02 |