510(k) K893622
K893622 is an FDA 510(k) premarket notification submitted by Preemicare Corp. for the device "PREEMICARE MODEL 200-II INFANT TRANSPORT VENTIL.". The FDA issued a decision of Substantially Equivalent on January 3, 1990. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Preemicare Corp. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 3, 1990
- Date Received
- May 11, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ventilator, Continuous, Facility Use
- Device Class
- Class II
- Regulation Number
- 868.5895
- Review Panel
- AN
- Submission Type