The following data is part of a premarket notification filed by Ventlab Corp. with the FDA for Ventlab Nasal Cpap Cannula.
| Device ID | K040726 |
| 510k Number | K040726 |
| Device Name: | VENTLAB NASAL CPAP CANNULA |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | VENTLAB CORP. 2934 HWY. 601 NORTH Mocksville, NC 27028 |
| Contact | Robert M Kelly |
| Correspondent | Robert M Kelly VENTLAB CORP. 2934 HWY. 601 NORTH Mocksville, NC 27028 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-22 |
| Decision Date | 2004-06-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20889483111748 | K040726 | 000 |
| 20889483096168 | K040726 | 000 |
| 20889483094300 | K040726 | 000 |
| 20889483093891 | K040726 | 000 |
| 20889483093884 | K040726 | 000 |
| 20889483092634 | K040726 | 000 |
| 20889483091569 | K040726 | 000 |
| 20889483084233 | K040726 | 000 |
| 20889483084219 | K040726 | 000 |
| 20889483083045 | K040726 | 000 |
| 20889483082529 | K040726 | 000 |
| 20889483081812 | K040726 | 000 |
| 20889483081805 | K040726 | 000 |
| 20889483081478 | K040726 | 000 |
| 20889483081461 | K040726 | 000 |
| 20889483080709 | K040726 | 000 |
| 20889483079994 | K040726 | 000 |
| 20889483097608 | K040726 | 000 |
| 20889483098223 | K040726 | 000 |
| 20889483110246 | K040726 | 000 |
| 20889483110000 | K040726 | 000 |
| 20889483109820 | K040726 | 000 |
| 20889483109813 | K040726 | 000 |
| 20889483108038 | K040726 | 000 |
| 20889483107352 | K040726 | 000 |
| 20889483106331 | K040726 | 000 |
| 20889483106324 | K040726 | 000 |
| 20889483105495 | K040726 | 000 |
| 10889483104767 | K040726 | 000 |
| 20889483104047 | K040726 | 000 |
| 20889483103644 | K040726 | 000 |
| 20889483103637 | K040726 | 000 |
| 20889483102463 | K040726 | 000 |
| 20889483101831 | K040726 | 000 |
| 20889483101541 | K040726 | 000 |
| 20889483077839 | K040726 | 000 |