K863890 is an FDA 510(k) clearance for the MAMM-AIRE. This device is classified as a Cradle, Patient, Radiologic (Class I - General Controls, product code KXH).
Submitted by Ar Custom Medical Products, Ltd. (Deer Park, US). The FDA issued a Cleared decision on October 14, 1986, 8 days after receiving the submission on October 6, 1986.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1830.
| 510(k) Number | K863890 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 06, 1986 |
| Decision Date | October 14, 1986 |
| Days to Decision | 8 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | KXH — Cradle, Patient, Radiologic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.1830 |