510(k) K823861
K823861 is an FDA 510(k) premarket notification submitted by Bio-Med Devices, Inc. for the device "ET-3 EMERGENCY TRANSPORT VENTILATOR". The FDA issued a decision of Substantially Equivalent on February 7, 1983. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Bio-Med Devices, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 7, 1983
- Date Received
- December 22, 1982
- 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