510(k) K873043
K873043 is an FDA 510(k) premarket notification submitted by Artec Environmental Monitoring Division for the device "MOUTH TO FACE RESUSCITATOR". The FDA issued a decision of Substantially Equivalent on September 28, 1987. The device falls under product code BTM (Ventilator, Emergency, Manual (Resuscitator)), a Class II device regulated under 21 CFR 868.5915. Artec Environmental Monitoring Division has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 28, 1987
- Date Received
- August 4, 1987
- 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