The following data is part of a premarket notification filed by Novametrix Medical Systems, Inc. with the FDA for Model 840 Transcutan. Oxygen/carbon Diox. Monitor.
| Device ID | K870805 |
| 510k Number | K870805 |
| Device Name: | MODEL 840 TRANSCUTAN. OXYGEN/CARBON DIOX. MONITOR |
| Classification | Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia |
| Applicant | NOVAMETRIX MEDICAL SYSTEMS, INC. 1 BARNES INDUSTRIAL PARK RD. P.O. BOX 690 Wallingford, CT 06492 |
| Contact | Robert Schiffman |
| Correspondent | Robert Schiffman NOVAMETRIX MEDICAL SYSTEMS, INC. 1 BARNES INDUSTRIAL PARK RD. P.O. BOX 690 Wallingford, CT 06492 |
| Product Code | KLK |
| CFR Regulation Number | 868.2500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-03 |
| Decision Date | 1987-05-27 |