510(k) K932014
K932014 is an FDA 510(k) premarket notification submitted by Ambu, Inc. for the device "AMBU DISPOSABLE FACE MASK". The FDA issued a decision of Substantially Equivalent on June 22, 1993. The device falls under product code BSJ (Mask, Gas, Anesthetic), a Class I device regulated under 21 CFR 868.5550. Ambu, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 22, 1993
- Date Received
- April 23, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mask, Gas, Anesthetic
- Device Class
- Class I
- Regulation Number
- 868.5550
- Review Panel
- AN
- Submission Type