510(k) K992743
K992743 is an FDA 510(k) premarket notification submitted by Collins Medical, Inc. for the device "COLLINS CPL". The FDA issued a decision of Substantially Equivalent on September 13, 1999. The device falls under product code BZG (Spirometer, Diagnostic), a Class II device regulated under 21 CFR 868.1840. Collins Medical, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 13, 1999
- Date Received
- August 16, 1999
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Spirometer, Diagnostic
- Device Class
- Class II
- Regulation Number
- 868.1840
- Review Panel
- AN
- Submission Type