510(k) K030464
K030464 is an FDA 510(k) premarket notification submitted by Collins Medical, Inc. for the device "GEM, MODEL 004110". The FDA issued a decision of Substantially Equivalent on March 14, 2003. 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
- March 14, 2003
- Date Received
- February 12, 2003
- 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