The following data is part of a premarket notification filed by Medex, Inc. with the FDA for Novatrans Ii.
| Device ID | K951129 |
| 510k Number | K951129 |
| Device Name: | NOVATRANS II |
| Classification | Transducer, Blood-pressure, Extravascular |
| Applicant | MEDEX, INC. 3637 LACON RD. Hilliard, OH 43026 |
| Contact | Cathy Chenetski |
| Correspondent | Cathy Chenetski MEDEX, INC. 3637 LACON RD. Hilliard, OH 43026 |
| Product Code | DRS |
| CFR Regulation Number | 870.2850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-13 |
| Decision Date | 1995-04-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50351688504560 | K951129 | 000 |
| 50351688504331 | K951129 | 000 |
| 50351688504324 | K951129 | 000 |
| 50351688504317 | K951129 | 000 |
| 50351688504300 | K951129 | 000 |
| 50351688504294 | K951129 | 000 |
| 50351688504287 | K951129 | 000 |
| 50351688504270 | K951129 | 000 |
| 50351688504263 | K951129 | 000 |
| 50351688504256 | K951129 | 000 |
| 50351688504249 | K951129 | 000 |
| 50351688504133 | K951129 | 000 |
| 50351688501545 | K951129 | 000 |
| 50351688504348 | K951129 | 000 |
| 50351688504362 | K951129 | 000 |
| 50351688504393 | K951129 | 000 |
| 50351688504553 | K951129 | 000 |
| 50351688504546 | K951129 | 000 |
| 50351688504539 | K951129 | 000 |
| 50351688504515 | K951129 | 000 |
| 50351688504508 | K951129 | 000 |
| 50351688504492 | K951129 | 000 |
| 50351688504485 | K951129 | 000 |
| 50351688504478 | K951129 | 000 |
| 50351688504461 | K951129 | 000 |
| 50351688504454 | K951129 | 000 |
| 50351688504416 | K951129 | 000 |
| 50351688504409 | K951129 | 000 |
| 50351688501538 | K951129 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() NOVATRANS II 73811807 1590721 Dead/Cancelled |
MEDEX, INC. 1989-07-10 |