K760618 is an FDA 510(k) clearance for the PATIENT RESTRAINT. This device is classified as a Restraint, Protective (Class I - General Controls, product code FMQ).
Submitted by Encompass Group, LLC (Mchenry, US). The FDA issued a Cleared decision on November 24, 1976, 72 days after receiving the submission on September 13, 1976.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6760.
| 510(k) Number | K760618 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 13, 1976 |
| Decision Date | November 24, 1976 |
| Days to Decision | 72 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | - |
| Product Code | FMQ - Restraint, Protective |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.6760 |