510(k) K040991
K040991 is an FDA 510(k) premarket notification submitted by Ambu, Inc. for the device "AMBU DISPOSABLE PRESSURE MANOMETER". The FDA issued a decision of Substantially Equivalent on July 22, 2004. The device falls under product code CAP (Monitor, Airway Pressure (Includes Gauge And/Or Alarm)), a Class II device regulated under 21 CFR 868.2600. Ambu, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 22, 2004
- Date Received
- April 16, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
- Device Class
- Class II
- Regulation Number
- 868.2600
- Review Panel
- AN
- Submission Type