The following data is part of a premarket notification filed by Sentel Tech. C/o Criticare Systems, Inc. with the FDA for Sam(tm) Model One.
| Device ID | K880725 |
| 510k Number | K880725 |
| Device Name: | SAM(TM) MODEL ONE |
| Classification | Monitor, Breathing Frequency |
| Applicant | SENTEL TECH. C/O CRITICARE SYSTEMS, INC. 10054 PROSPECT AVE. SUITE B Santee, CA 92071 |
| Contact | Lai, Ph.d. |
| Correspondent | Lai, Ph.d. SENTEL TECH. C/O CRITICARE SYSTEMS, INC. 10054 PROSPECT AVE. SUITE B Santee, CA 92071 |
| Product Code | BZQ |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-23 |
| Decision Date | 1988-09-06 |