510(k) K912946
K912946 is an FDA 510(k) premarket notification submitted by Warren E. Collins, Inc. for the device "COLLINS DIGITAL PULMONARY MANOMETER". The FDA issued a decision of Substantially Equivalent on January 15, 1992. The device falls under product code BXR (Meter, Airway Pressure (Inspiratory Force)), a Class II device regulated under 21 CFR 868.1780. Warren E. Collins, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 15, 1992
- Date Received
- July 5, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Meter, Airway Pressure (Inspiratory Force)
- Device Class
- Class II
- Regulation Number
- 868.1780
- Review Panel
- AN
- Submission Type