510(k) K872558
K872558 is an FDA 510(k) premarket notification submitted by Nico Metal Products Corp. for the device "CART, EMERGENCY, CARDIOPULMONARY". The FDA issued a decision of Substantially Equivalent on July 24, 1987. The device falls under product code BZN (Cart, Emergency, Cardiopulmonary (Excluding Equipment)), a Class I device regulated under 21 CFR 868.6175.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 24, 1987
- Date Received
- June 29, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cart, Emergency, Cardiopulmonary (Excluding Equipment)
- Device Class
- Class I
- Regulation Number
- 868.6175
- Review Panel
- AN
- Submission Type