510(k) K002846
K002846 is an FDA 510(k) premarket notification submitted by Headstar Medical Products Co., Ltd. for the device "HEADSTAR'S MANUAL EMERGENCY RESUSCITATOR". The FDA issued a decision of Substantially Equivalent on Jun 6, 2001. The device falls under product code BTM (Ventilator, Emergency, Manual (Resuscitator)), a Class II device regulated under 21 CFR 868.5915. Headstar Medical Products Co., Ltd. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 6, 2001
- Date Received
- Sep 12, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ventilator, Emergency, Manual (Resuscitator)
- Device Class
- Class II
- Regulation Number
- 868.5915
- Review Panel
- AN
- Submission Type
- 510(k)