510(k) K832697
K832697 is an FDA 510(k) premarket notification submitted by Rmp Co. for the device "RMP INTUBATION EQUIP. STORAGE TRAY". The FDA issued a decision of Substantially Equivalent on December 27, 1983. The device falls under product code BZN (Cart, Emergency, Cardiopulmonary (Excluding Equipment)), a Class I device regulated under 21 CFR 868.6175. Rmp Co. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 27, 1983
- Date Received
- August 10, 1983
- 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