510(k) K092685
K092685 is an FDA 510(k) premarket notification submitted by Salter Labs for the device "PNEUMOTHERML, MODEL: 5800". The FDA issued a decision of Substantially Equivalent on November 24, 2009. The device falls under product code BZQ (Monitor, Breathing Frequency), a Class II device regulated under 21 CFR 868.2375. Salter Labs has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 24, 2009
- Date Received
- September 2, 2009
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Breathing Frequency
- Device Class
- Class II
- Regulation Number
- 868.2375
- Review Panel
- AN
- Submission Type