510(k) K843977
K843977 is an FDA 510(k) premarket notification submitted by James J. Lally for the device "PULSE-AID DEVICE". The FDA issued a decision of Substantially Equivalent on February 1, 1985. The device falls under product code LIX (Aid, Cardiopulmonary Resuscitation), a Class II device regulated under 21 CFR 870.5210.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 1, 1985
- Date Received
- October 5, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Aid, Cardiopulmonary Resuscitation
- Device Class
- Class II
- Regulation Number
- 870.5210
- Review Panel
- CV
- Submission Type
CPR Aid device WITH feedback (visual, audio or both) on one or more CPR parameters (e.g., rate, depth, ventilation ratio, etc.), and contains software. Provides real-time feedback on CPR performance. Feedback can be audio, visual or both. Device contains software