The following data is part of a premarket notification filed by Sechrist with the FDA for Hbo Cable Assembly, Radiometer Tc-02.
Device ID | K905225 |
510k Number | K905225 |
Device Name: | HBO CABLE ASSEMBLY, RADIOMETER TC-02 |
Classification | Monitor, Carbon-dioxide, Cutaneous |
Applicant | SECHRIST 2820 GRETTA LN. Anaheim, CA 92306 |
Contact | Sandra Davis |
Correspondent | Sandra Davis SECHRIST 2820 GRETTA LN. Anaheim, CA 92306 |
Product Code | LKD |
CFR Regulation Number | 868.2480 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-11-20 |
Decision Date | 1991-04-10 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00899660002918 | K905225 | 000 |
00899660002901 | K905225 | 000 |
00899660002895 | K905225 | 000 |