K810035 is an FDA 510(k) clearance for the PRENATAL SUPPORT PILLOW. This device is classified as a Support, Patient Position (Class I - General Controls, product code CCX).
Submitted by Supportech, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 23, 1981, 14 days after receiving the submission on January 9, 1981.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.6820.
| 510(k) Number | K810035 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 09, 1981 |
| Decision Date | January 23, 1981 |
| Days to Decision | 14 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | CCX — Support, Patient Position |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.6820 |