K972123 is an FDA 510(k) clearance for the PROTECTIVE RESTRAINT MODELS #302,440,750,850,AND905. This device is classified as a Restraint, Protective (Class I - General Controls, product code FMQ).
Submitted by Smith (Crofton, US). The FDA issued a Cleared decision on July 25, 1997, 50 days after receiving the submission on June 5, 1997.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6760.
| 510(k) Number | K972123 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 05, 1997 |
| Decision Date | July 25, 1997 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FMQ — Restraint, Protective |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.6760 |