Submission Details
| 510(k) Number | K981376 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 16, 1998 |
| Decision Date | January 04, 1999 |
| Days to Decision | 263 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
HEWLETT-PACKARD M1205A VIRIDIA 24 CT
Jan 1999
Decision
263d
Days
Class 2
Risk
About This 510(k) Submission
K981376 is an FDA 510(k) clearance for the HEWLETT-PACKARD M1205A VIRIDIA 24 CT, a Detector And Alarm, Arrhythmia (Class II — Special Controls, product code DSI), submitted by Hewlett-Packard Co. (Andover, US). The FDA issued a Cleared decision on January 4, 1999, 263 days after receiving the submission on April 16, 1998. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.
Device Classification
| Product Code | DSI — Detector And Alarm, Arrhythmia |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1025 |
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