Submission Details
| 510(k) Number | K974567 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 05, 1997 |
| Decision Date | January 20, 1998 |
| Days to Decision | 46 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
HEWLETT-PACKARD M2605A VIRIDIA WAVE VIEWER
Jan 1998
Decision
46d
Days
Class 2
Risk
About This 510(k) Submission
K974567 is an FDA 510(k) clearance for the HEWLETT-PACKARD M2605A VIRIDIA WAVE VIEWER, a System, Network And Communication, Physiological Monitors (Class II — Special Controls, product code MSX), submitted by Hewlett-Packard Co. (Andover, US). The FDA issued a Cleared decision on January 20, 1998, 46 days after receiving the submission on December 5, 1997. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.
Device Classification
| Product Code | MSX — System, Network And Communication, Physiological Monitors |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.2300 |
Manufacturer
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