The following data is part of a premarket notification filed by Mennen Medical, Inc. with the FDA for Four-channel/eight-channel Thermal Array Recorder.
| Device ID | K884897 |
| 510k Number | K884897 |
| Device Name: | FOUR-CHANNEL/EIGHT-CHANNEL THERMAL ARRAY RECORDER |
| Classification | Recorder, Paper Chart |
| Applicant | MENNEN MEDICAL, INC. 10123 MAIN ST. Clarence, NY 14031 |
| Contact | Thomas W Connelly |
| Correspondent | Thomas W Connelly MENNEN MEDICAL, INC. 10123 MAIN ST. Clarence, NY 14031 |
| Product Code | DSF |
| CFR Regulation Number | 870.2810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-23 |
| Decision Date | 1989-03-09 |