Submission Details
| 510(k) Number | K974087 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 29, 1997 |
| Decision Date | June 15, 1998 |
| Days to Decision | 229 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
MODEL M1792A THROMBOLYTIC PREDICTIVE INSTRUMENT
Jun 1998
Decision
229d
Days
—
Risk
About This 510(k) Submission
K974087 is an FDA 510(k) clearance for the MODEL M1792A THROMBOLYTIC PREDICTIVE INSTRUMENT, submitted by Hewlett-Packard Co. (Andover, US). The FDA issued a Cleared decision on June 15, 1998, 229 days after receiving the submission on October 29, 1997. This device falls under the Cardiovascular review panel.
Device Classification
| Product Code | LOS |
| Device Class | — |
Manufacturer
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