510(k) K972283
K972283 is an FDA 510(k) premarket notification submitted by Sims for the device "SIMS 1ST RESPONSE MANUAL RESUSCITATOR, ADULT". The FDA issued a decision of Substantially Equivalent on September 17, 1997. The device falls under product code BTM (Ventilator, Emergency, Manual (Resuscitator)), a Class II device regulated under 21 CFR 868.5915. Sims has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 17, 1997
- Date Received
- June 19, 1997
- 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