Submission Details
| 510(k) Number | K993171 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 21, 1999 |
| Decision Date | October 21, 1999 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
HP VIRIDIA INFORMATION SYSTEM, MODELS M3150A/ M3151A/ M3153A/ M3154A
Oct 1999
Decision
30d
Days
Class 2
Risk
About This 510(k) Submission
K993171 is an FDA 510(k) clearance for the HP VIRIDIA INFORMATION SYSTEM, MODELS M3150A/ M3151A/ M3153A/ M3154A, 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 October 21, 1999, 30 days after receiving the submission on September 21, 1999. 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 |
Manufacturer
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