510(k) K992636
K992636 is an FDA 510(k) premarket notification submitted by Hewlett-Packard Co. for the device "HP CAREVUE 9000 CLINICAL INFORMATION SYSTEM, MODEL M2331A". The FDA issued a decision of Substantially Equivalent on August 31, 1999. The device falls under product code DXJ (Display, Cathode-Ray Tube, Medical), a Class II device regulated under 21 CFR 870.2450. Hewlett-Packard Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 31, 1999
- Date Received
- August 6, 1999
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Display, Cathode-Ray Tube, Medical
- Device Class
- Class II
- Regulation Number
- 870.2450
- Review Panel
- CV
- Submission Type