The following data is part of a premarket notification filed by Mennen Medical, Inc. with the FDA for Model 219 Telemetry System.
| Device ID | K895895 |
| 510k Number | K895895 |
| Device Name: | MODEL 219 TELEMETRY SYSTEM |
| Classification | Encephalogram Telemetry System |
| Applicant | MENNEN MEDICAL, INC. 10123 MAIN ST. Clarence, NY 14031 |
| Contact | Richard G Whitehead |
| Correspondent | Richard G Whitehead MENNEN MEDICAL, INC. 10123 MAIN ST. Clarence, NY 14031 |
| Product Code | GYE |
| CFR Regulation Number | 882.1855 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-06 |
| Decision Date | 1990-02-22 |