510(k) K881643
K881643 is an FDA 510(k) premarket notification submitted by Dowit Service Co., Inc. for the device "BATTERY PACKS FOR CARDIOVASCULAR UNITS". The FDA issued a decision of Substantially Equivalent on May 17, 1988. The device falls under product code MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.1025. Dowit Service Co., Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 17, 1988
- Date Received
- April 4, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- Device Class
- Class II
- Regulation Number
- 870.1025
- Review Panel
- CV
- Submission Type