510(k) K160253
K160253 is an FDA 510(k) premarket notification submitted by Vitalograph (Ireland) , Ltd. for the device "Vitalograph Model 6300 micro". The FDA issued a decision of Substantially Equivalent on Aug 26, 2016. 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
- Aug 26, 2016
- Date Received
- Feb 1, 2016
- Clearance Type
- Traditional
- 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