The following data is part of a premarket notification filed by Green Field Medical Sourcing, Inc. with the FDA for Ventilator, Emergency, Manual (resuscitator).
| Device ID | K954150 |
| 510k Number | K954150 |
| Device Name: | VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | GREEN FIELD MEDICAL SOURCING, INC. 910 BOSTON TURNPIKE RD. Shrewsbury, MA 01545 |
| Contact | Brian Swanson |
| Correspondent | Brian Swanson GREEN FIELD MEDICAL SOURCING, INC. 910 BOSTON TURNPIKE RD. Shrewsbury, MA 01545 |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-05 |
| Decision Date | 1995-12-20 |