The following data is part of a premarket notification filed by Smiths Medical International, Ltd. with the FDA for Pneupac Vr1 Air Mix.
| Device ID | K071527 |
| 510k Number | K071527 |
| Device Name: | PNEUPAC VR1 AIR MIX |
| Classification | Ventilator, Emergency, Powered (resuscitator) |
| Applicant | SMITHS MEDICAL INTERNATIONAL, LTD. N7 W22025 JOHNSON DRIVE Waukesha, WI 53186 |
| Contact | Donald Alexander |
| Correspondent | Donald Alexander SMITHS MEDICAL INTERNATIONAL, LTD. N7 W22025 JOHNSON DRIVE Waukesha, WI 53186 |
| Product Code | BTL |
| CFR Regulation Number | 868.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-04 |
| Decision Date | 2007-10-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 35019315074862 | K071527 | 000 |