The following data is part of a premarket notification filed by Micro-tech Medical, Inc. with the FDA for Informer Plus.
| Device ID | K943481 |
| 510k Number | K943481 |
| Device Name: | INFORMER PLUS |
| Classification | Monitor, Bed Patient |
| Applicant | MICRO-TECH MEDICAL, INC. 107 BURNSIDE AVE. East Hartford, CT 06108 |
| Contact | Keith Charles |
| Correspondent | Keith Charles MICRO-TECH MEDICAL, INC. 107 BURNSIDE AVE. East Hartford, CT 06108 |
| Product Code | KMI |
| CFR Regulation Number | 880.2400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-19 |
| Decision Date | 1994-11-02 |