510(k) K872278
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 3, 1987
- Date Received
- June 15, 1987
- 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