The following data is part of a premarket notification filed by Spectramed, Inc. with the FDA for Safe-draw(tm) Blood Sampling Reservoir & Access..
| Device ID | K885235 |
| 510k Number | K885235 |
| Device Name: | SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS. |
| Classification | Computer, Blood-pressure |
| Applicant | SPECTRAMED, INC. 1900 WILLIAMS DR. Oxnard, CA 93030 |
| Contact | Robert L Leavitt |
| Correspondent | Robert L Leavitt SPECTRAMED, INC. 1900 WILLIAMS DR. Oxnard, CA 93030 |
| Product Code | DSK |
| CFR Regulation Number | 870.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-20 |
| Decision Date | 1989-01-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884450372535 | K885235 | 000 |