Submission Details
| 510(k) Number | K980429 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 04, 1998 |
| Decision Date | September 09, 1998 |
| Days to Decision | 217 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
HP M2600A VIRIDIA TELEMETRY SYSTEM (FORMERLY KNOWN AS THE HP 2600A OMNI-CARE TELEMETRY SYSTEM)
Sep 1998
Decision
217d
Days
Class 2
Risk
About This 510(k) Submission
K980429 is an FDA 510(k) clearance for the HP M2600A VIRIDIA TELEMETRY SYSTEM (FORMERLY KNOWN AS THE HP 2600A OMNI-CARE 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 September 9, 1998, 217 days after receiving the submission on February 4, 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 |
Manufacturer
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