510(k) K040194
K040194 is an FDA 510(k) premarket notification submitted by Compumedics USA, Ltd. for the device "COMPUMEDICS SUMMIT IP". The FDA issued a decision of Substantially Equivalent on April 23, 2004. The device falls under product code MNR (Ventilatory Effort Recorder), a Class II device regulated under 21 CFR 868.2375. Compumedics USA, Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 23, 2004
- Date Received
- January 28, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ventilatory Effort Recorder
- Device Class
- Class II
- Regulation Number
- 868.2375
- Review Panel
- AN
- Submission Type