K904556 is an FDA 510(k) clearance for the MANSFIELD CARDIAC ASSIST MODEL 940(TM) IAB. This device is classified as a Treadmill, Powered (Class I - General Controls, product code IOL).
Submitted by Boston Scientific Corp (San Jose, US). The FDA issued a Cleared decision on December 18, 1991, 439 days after receiving the submission on October 5, 1990.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5380.
| 510(k) Number | K904556 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 05, 1990 |
| Decision Date | December 18, 1991 |
| Days to Decision | 439 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | IOL — Treadmill, Powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.5380 |