The following data is part of a premarket notification filed by Smiths Medical Asd, Inc. with the FDA for Hemodraw Arterial Blood Sampling System.
| Device ID | K071269 |
| 510k Number | K071269 |
| Device Name: | HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEM |
| Classification | Arterial Blood Sampling Kit |
| Applicant | SMITHS MEDICAL ASD, INC. 6250 SHIER RINGS RD. Dublin, OH 40316 |
| Contact | Barbara Law |
| Correspondent | Barbara Law SMITHS MEDICAL ASD, INC. 6250 SHIER RINGS RD. Dublin, OH 40316 |
| Product Code | CBT |
| CFR Regulation Number | 868.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-07 |
| Decision Date | 2007-08-01 |