K980509 is an FDA 510(k) clearance for the DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS. This device is classified as a Pack, Hot Or Cold, Disposable (Class I - General Controls, product code IMD).
Submitted by Deroyal Industries, Inc. (Powell, US). The FDA issued a Cleared decision on February 26, 1998, 16 days after receiving the submission on February 10, 1998.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5710.
| 510(k) Number | K980509 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 10, 1998 |
| Decision Date | February 26, 1998 |
| Days to Decision | 16 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | IMD — Pack, Hot Or Cold, Disposable |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.5710 |