Submission Details
| 510(k) Number | K993516 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 18, 1999 |
| Decision Date | November 08, 1999 |
| Days to Decision | 21 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
HP M2600A VIRIDIA TELEMETRY SYSTEM
Nov 1999
Decision
21d
Days
Class 2
Risk
About This 510(k) Submission
K993516 is an FDA 510(k) clearance for the HP M2600A VIRIDIA TELEMETRY SYSTEM, 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 November 8, 1999, 21 days after receiving the submission on October 18, 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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