K991159 is an FDA 510(k) clearance for the PRISMATHERM II, ASTOLINE. This device is classified as a Warmer, Blood, Non-electromagnetic Radiation (Class II - Special Controls, product code BSB).
Submitted by Stihler Electronic GmbH (Sound Beach, US). The FDA issued a Cleared decision on September 3, 1999, 149 days after receiving the submission on April 7, 1999.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.9205.
| 510(k) Number | K991159 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 07, 1999 |
| Decision Date | September 03, 1999 |
| Days to Decision | 149 days |
| Submission Type | Abbreviated |
| Review Panel | Hematology (HE) |
| Summary | Statement |
| Product Code | BSB - Warmer, Blood, Non-electromagnetic Radiation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.9205 |