K963528 is an FDA 510(k) clearance for the ALIMED POSITIONING 7 SAFETY STRAPS (THREE TYPES), UNIVERSAL CR/MRI WIDE BODY STRAP, UNIVERSAL CT SCANNER STRAP (2 SIZES). This device is classified as a Restraint, Protective (Class I - General Controls, product code FMQ).
Submitted by Alimed, Inc. (Dedham, US). The FDA issued a Cleared decision on October 29, 1996, 55 days after receiving the submission on September 4, 1996.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6760.
| 510(k) Number | K963528 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 04, 1996 |
| Decision Date | October 29, 1996 |
| Days to Decision | 55 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMQ — Restraint, Protective |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.6760 |