510(k) K944667
K944667 is an FDA 510(k) premarket notification submitted by Green Field Medical Sourcing, Inc. for the device "LIFE PULSE TESUSCITATION TIMER". The FDA issued a decision of Substantially Equivalent on October 4, 1994. The device falls under product code PMK (Cpr Aid Device Without Feedback), a Class I device regulated under 21 CFR 870.5210. Green Field Medical Sourcing, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 4, 1994
- Date Received
- September 20, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cpr Aid Device Without Feedback
- Device Class
- Class I
- Regulation Number
- 870.5210
- Review Panel
- CV
- Submission Type
A device that performs a simple function such as proper hand placement and/or simple prompting for rate and/or timing of compressions/breathing for the professionally trained rescuer, but offers no feedback related to the quality of the CPR being provided. These devices are intended for use by persons professionally trained in CPR to assure proper use and the delivery of optimal CPR to the victim.