The following data is part of a premarket notification filed by Novametrix Medical Systems, Inc. with the FDA for Novametrix Model 200 Magstim.
| Device ID | K871338 |
| 510k Number | K871338 |
| Device Name: | NOVAMETRIX MODEL 200 MAGSTIM |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | NOVAMETRIX MEDICAL SYSTEMS, INC. 45 WEST ST. SUITE 2 Attleboro, MA 02703 |
| Contact | James R Veale |
| Correspondent | James R Veale NOVAMETRIX MEDICAL SYSTEMS, INC. 45 WEST ST. SUITE 2 Attleboro, MA 02703 |
| Product Code | GWF |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-03 |
| Decision Date | 1987-08-04 |