K900419 is an FDA 510(k) clearance for the CRYOTRON-UL30. This device is classified as a Unit, Chilling (Class I - General Controls, product code IMF).
Submitted by Henley Intl. (Sugar Land, US). The FDA issued a Cleared decision on February 27, 1990, 28 days after receiving the submission on January 30, 1990.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5940.
| 510(k) Number | K900419 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 30, 1990 |
| Decision Date | February 27, 1990 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | IMF — Unit, Chilling |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.5940 |