The following data is part of a premarket notification filed by Peace Medical, Inc. with the FDA for Peace Model 100 Cuff Monitor.
| Device ID | K912352 |
| 510k Number | K912352 |
| Device Name: | PEACE MODEL 100 CUFF MONITOR |
| Classification | Cuff, Tracheal Tube, Inflatable |
| Applicant | PEACE MEDICAL, INC. 50 S.CENTER ST. SUITE 11 Orange, NJ 07050 |
| Contact | Kevin Fegan |
| Correspondent | Kevin Fegan PEACE MEDICAL, INC. 50 S.CENTER ST. SUITE 11 Orange, NJ 07050 |
| Product Code | BSK |
| CFR Regulation Number | 868.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-28 |
| Decision Date | 1991-08-02 |