510(k) K801022
K801022 is an FDA 510(k) premarket notification submitted by Powers Medical Systmes for the device "ULTRA-CHEK PACEMAKER MONITOR". The FDA issued a decision of Substantially Equivalent on June 17, 1980. The device falls under product code KRE (Analyzer, Pacemaker Generator Function, Indirect), a Class II device regulated under 21 CFR 870.3640. Powers Medical Systmes has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 17, 1980
- Date Received
- April 30, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Pacemaker Generator Function, Indirect
- Device Class
- Class II
- Regulation Number
- 870.3640
- Review Panel
- CV
- Submission Type