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 |