The following data is part of a premarket notification filed by Vivascience, Inc. with the FDA for Vivapore 2.
| Device ID | K943966 |
| 510k Number | K943966 |
| Device Name: | VIVAPORE 2 |
| Classification | Clinical Sample Concentrator |
| Applicant | VIVASCIENCE, INC. P.O. BOX 2240 Acton, MA 01720 |
| Contact | Denis B Hunt |
| Correspondent | Denis B Hunt VIVASCIENCE, INC. P.O. BOX 2240 Acton, MA 01720 |
| Product Code | JJH |
| CFR Regulation Number | 862.2310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-28 |
| Decision Date | 1995-04-11 |