Submission Details
| 510(k) Number | K992636 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 06, 1999 |
| Decision Date | August 31, 1999 |
| Days to Decision | 25 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
HP CAREVUE 9000 CLINICAL INFORMATION SYSTEM, MODEL M2331A
Aug 1999
Decision
25d
Days
Class 2
Risk
About This 510(k) Submission
K992636 is an FDA 510(k) clearance for the HP CAREVUE 9000 CLINICAL INFORMATION SYSTEM, MODEL M2331A, a Display, Cathode-ray Tube, Medical (Class II — Special Controls, product code DXJ), submitted by Hewlett-Packard Co. (Andover, US). The FDA issued a Cleared decision on August 31, 1999, 25 days after receiving the submission on August 6, 1999. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2450.
Device Classification
| Product Code | DXJ — Display, Cathode-ray Tube, Medical |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.2450 |
Manufacturer
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