The following data is part of a premarket notification filed by Smiths Medical International, Ltd. with the FDA for Pneupac Vri Standard, Model Vristdnus, Pneupac Vri Responder, Model Vriresnus.
| Device ID | K051322 |
| 510k Number | K051322 |
| Device Name: | PNEUPAC VRI STANDARD, MODEL VRISTDNUS, PNEUPAC VRI RESPONDER, MODEL VRIRESNUS |
| Classification | Ventilator, Emergency, Powered (resuscitator) |
| Applicant | SMITHS MEDICAL INTERNATIONAL, LTD. N7 W22025 JOHNSON DRIVE Waukesha, WI |
| Contact | Donald Alexander |
| Correspondent | Donald Alexander SMITHS MEDICAL INTERNATIONAL, LTD. N7 W22025 JOHNSON DRIVE Waukesha, WI |
| Product Code | BTL |
| CFR Regulation Number | 868.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-20 |
| Decision Date | 2005-08-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15019517189513 | K051322 | 000 |