The following data is part of a premarket notification filed by Green Field Medical Sourcing, Inc. with the FDA for Life Pulse Tesuscitation Timer.
Device ID | K944667 |
510k Number | K944667 |
Device Name: | LIFE PULSE TESUSCITATION TIMER |
Classification | Device, Cpr Assist |
Applicant | GREEN FIELD MEDICAL SOURCING, INC. 910 BOSTON TURNPIKE RD. Shrewsbury, MA 01545 |
Contact | Donald R Gorsuch |
Correspondent | Donald R Gorsuch GREEN FIELD MEDICAL SOURCING, INC. 910 BOSTON TURNPIKE RD. Shrewsbury, MA 01545 |
Product Code | LYM |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-09-20 |
Decision Date | 1994-10-04 |