K870832 is an FDA 510(k) clearance for the OXY-THERM. This device is classified as a Pack, Hot Or Cold, Disposable (Class I - General Controls, product code IMD).
Submitted by M.D. Intl., Inc. (Hermosa Beach, US). The FDA issued a Cleared decision on March 12, 1987, 9 days after receiving the submission on March 3, 1987.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5710.
| 510(k) Number | K870832 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 03, 1987 |
| Decision Date | March 12, 1987 |
| Days to Decision | 9 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | IMD — Pack, Hot Or Cold, Disposable |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.5710 |