The following data is part of a premarket notification filed by Novametrix Medical Systems, Inc. with the FDA for Co 2 Smo Plus.
| Device ID | K963380 |
| 510k Number | K963380 |
| Device Name: | CO 2 SMO PLUS |
| Classification | Calculator, Pulmonary Function Data |
| Applicant | NOVAMETRIX MEDICAL SYSTEMS, INC. 1 BARNES INDUSTRIAL PARK RD. P.O. BOX 690 Wallingford, CT 06492 |
| Contact | Robert H Schiffman |
| Correspondent | Robert H Schiffman NOVAMETRIX MEDICAL SYSTEMS, INC. 1 BARNES INDUSTRIAL PARK RD. P.O. BOX 690 Wallingford, CT 06492 |
| Product Code | BZC |
| CFR Regulation Number | 868.1880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-27 |
| Decision Date | 1997-01-22 |