510(k) K141546
K141546 is an FDA 510(k) premarket notification submitted by Vitalograph (Ireland) , Ltd. for the device "VITALOGRAPH MODEL 7000 SPIROTRAC". The FDA issued a decision of Substantially Equivalent on Sep 3, 2014. The device falls under product code BZG (Spirometer, Diagnostic), a Class II device regulated under 21 CFR 868.1840. Vitalograph (Ireland) , Ltd. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 3, 2014
- Date Received
- Jun 10, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Spirometer, Diagnostic
- Device Class
- Class II
- Regulation Number
- 868.1840
- Review Panel
- AN
- Submission Type