510(k) K121770
K121770 is an FDA 510(k) premarket notification submitted by Headstar Medical Products Co., Ltd. for the device "HEADSTAR MEDICAL SMALL VOLUME JET NEBULIZER". The FDA issued a decision of Substantially Equivalent on Apr 17, 2013. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Headstar Medical Products Co., Ltd. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 17, 2013
- Date Received
- Jun 15, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Nebulizer (Direct Patient Interface)
- Device Class
- Class II
- Regulation Number
- 868.5630
- Review Panel
- AN
- Submission Type
- 510(k)