510(k) K102377
K102377 is an FDA 510(k) premarket notification submitted by A Plus Medical for the device "VENTIPLUS DISPOSABLE MANOMETER 0-60 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0-20 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0". The FDA issued a decision of Substantially Equivalent on November 18, 2010. 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. A Plus Medical has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 18, 2010
- Date Received
- August 20, 2010
- 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