Sam Model One
by Sentel Tech. C/O Criticare Systems, Inc. 510(k)
Active
510(k) K880725
Overview
The device is a Monitor, Breathing Frequency, as defined in the nomenclature authority data. It is classified under medical specialty Anesthesiology and device class 2.
It received FDA 510(k) clearance under K880725 on September 6, 1988, with a substantially equivalent decision. The product code is BZQ and the regulation number is 868.2375.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK880725 | Date6 Sep 1988 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Full name
- Sam(Tm) Model One
- 510(k) Number
- FDA Product Code
- BZQ
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.2375
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Questions
What is the SAM(TM) MODEL ONE used for?
The SAM(TM) MODEL ONE is a Monitor, Breathing Frequency device designed to measure and display respiratory rate in clinical environments, specifically within the anesthesiology specialty as indicated by its classification and product code BZQ.
How was the SAM(TM) MODEL ONE authorized for market distribution?
The device received FDA 510(k) clearance under submission K880725 on September 6, 1988, based on a determination of substantial equivalence to a legally marketed predicate device, following a traditional review process.
What regulatory classification applies to the SAM(TM) MODEL ONE?
The SAM(TM) MODEL ONE is classified as a Class 2 medical device under FDA regulations, with product code BZQ and regulation number 868.2375, placing it in the anesthesiology specialty monitoring category.