The following data is part of a premarket notification filed by Novametrix Medical Systems, Inc. with the FDA for Vent(ventcheck) Handheld Respiratory/mechanics Monitor Model 101.
| Device ID | K964360 |
| 510k Number | K964360 |
| Device Name: | VENT(VENTCHECK) HANDHELD RESPIRATORY/MECHANICS MONITOR MODEL 101 |
| Classification | Calculator, Pulmonary Function Data |
| Applicant | NOVAMETRIX MEDICAL SYSTEMS, INC. 56 CARPENTER LN. Wallingford, CT 06492 |
| Contact | Robert H Schiffman, R.a.c. |
| Correspondent | Robert H Schiffman, R.a.c. NOVAMETRIX MEDICAL SYSTEMS, INC. 56 CARPENTER LN. 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 | 1996-11-01 |
| Decision Date | 1997-04-04 |