The following data is part of a premarket notification filed by 3b Medical, Inc with the FDA for Ivolve Nasal Mask, Ivolve Full Face Mask, Ivolve N2.
| Device ID | K131901 |
| 510k Number | K131901 |
| Device Name: | IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2 |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | 3B MEDICAL, INC 21301 HWY 27 N Lake Wales, FL 33859 |
| Contact | Alex Lucio |
| Correspondent | Alex Lucio 3B MEDICAL, INC 21301 HWY 27 N Lake Wales, FL 33859 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-25 |
| Decision Date | 2013-12-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16948538360115 | K131901 | 000 |
| 06948538360583 | K131901 | 000 |
| 06948538360590 | K131901 | 000 |
| 06948538360606 | K131901 | 000 |
| 06948538360613 | K131901 | 000 |
| 06948538360620 | K131901 | 000 |
| 06948538362242 | K131901 | 000 |
| 06948538362259 | K131901 | 000 |
| 06948538360569 | K131901 | 000 |
| 16948538360092 | K131901 | 000 |
| 16948538360108 | K131901 | 000 |
| 06948538360576 | K131901 | 000 |