510(k) K791964
K791964 is an FDA 510(k) premarket notification submitted by Hewlett-Packard Co. for the device "MODEL 15055A MAINFRAME". The FDA issued a decision of Substantially Equivalent on Oct 11, 1979. The device falls under product code DRR (Amplifier And Signal Conditioner, Biopotential), a Class II device regulated under 21 CFR 870.2050. Hewlett-Packard Co. has 245 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 11, 1979
- Date Received
- Oct 1, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Amplifier And Signal Conditioner, Biopotential
- Device Class
- Class II
- Regulation Number
- 870.2050
- Review Panel
- CV
- Submission Type
- 510(k)