510(k) K901998
K901998 is an FDA 510(k) premarket notification submitted by Medical Support Products, Inc. for the device "DIGITAL MANOMETER (DM 50)". The FDA issued a decision of Substantially Equivalent on July 25, 1990. The device falls under product code BXR (Meter, Airway Pressure (Inspiratory Force)), a Class II device regulated under 21 CFR 868.1780.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 25, 1990
- Date Received
- May 2, 1990
- 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