The following data is part of a premarket notification filed by Smiths Medical International Ltd. with the FDA for Pneupac Parapac Plus.
| Device ID | K123957 |
| 510k Number | K123957 |
| Device Name: | PNEUPAC PARAPAC PLUS |
| Classification | Ventilator, Emergency, Powered (resuscitator) |
| Applicant | SMITHS MEDICAL INTERNATIONAL LTD. BRAMINGHAM BUSINESS PARK ENTERPRISE WAY Luton, Bedfordshire, GB Lu3 4bu |
| Contact | Lori Berends |
| Correspondent | Lori Berends SMITHS MEDICAL INTERNATIONAL LTD. BRAMINGHAM BUSINESS PARK ENTERPRISE WAY Luton, Bedfordshire, GB Lu3 4bu |
| Product Code | BTL |
| CFR Regulation Number | 868.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-21 |
| Decision Date | 2013-09-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 35019315107478 | K123957 | 000 |
| 35019315061077 | K123957 | 000 |
| 35019315061084 | K123957 | 000 |
| 35019315076101 | K123957 | 000 |
| 35019315076118 | K123957 | 000 |
| 45019315079208 | K123957 | 000 |
| 45019315079215 | K123957 | 000 |
| 35019517160219 | K123957 | 000 |
| 35019517160226 | K123957 | 000 |
| 15019517178845 | K123957 | 000 |
| 15019517180367 | K123957 | 000 |
| 15019517180374 | K123957 | 000 |
| 15019517180381 | K123957 | 000 |
| 35019315107263 | K123957 | 000 |
| 35019315107270 | K123957 | 000 |
| 35019315061060 | K123957 | 000 |