510(k) K943797
K943797 is an FDA 510(k) premarket notification submitted by Bpr Medical, Ltd. for the device "BABYCARE NEO2 OXYGEN CONCENTRATION CONTROLLER". The FDA issued a decision of Substantially Equivalent on May 11, 1995. The device falls under product code BZR (Mixer, Breathing Gases, Anesthesia Inhalation), a Class II device regulated under 21 CFR 868.5330. Bpr Medical, Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 11, 1995
- Date Received
- August 3, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mixer, Breathing Gases, Anesthesia Inhalation
- Device Class
- Class II
- Regulation Number
- 868.5330
- Review Panel
- AN
- Submission Type