The following data is part of a premarket notification filed by Childrens Medical Ventures Llc with the FDA for Neopap System.
| Device ID | K103410 |
| 510k Number | K103410 |
| Device Name: | NEOPAP SYSTEM |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | CHILDRENS MEDICAL VENTURES LLC SUITE 200, 3919 WILLIAM PENN HIGHWAY Murrysville, PA 15668 |
| Contact | Scott Wright |
| Correspondent | Scott Wright CHILDRENS MEDICAL VENTURES LLC SUITE 200, 3919 WILLIAM PENN HIGHWAY Murrysville, PA 15668 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-22 |
| Decision Date | 2011-03-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B0361110290 | K103410 | 000 |
| B0361074083 | K103410 | 000 |
| B0361074084 | K103410 | 000 |
| B0361074085 | K103410 | 000 |
| B0361074086 | K103410 | 000 |
| B0361074117 | K103410 | 000 |
| B0361074128 | K103410 | 000 |
| B0361078602 | K103410 | 000 |
| B0361074119 | K103410 | 000 |
| B0361074120 | K103410 | 000 |
| B0361074121 | K103410 | 000 |
| B0361074123 | K103410 | 000 |
| B0361074124 | K103410 | 000 |
| B0361078667 | K103410 | 000 |
| B0361074127 | K103410 | 000 |
| B0361076378 | K103410 | 000 |