The following data is part of a premarket notification filed by Narco Scientific with the FDA for Narco Telecare Transducer Dome #700-4000.
Device ID | K803096 |
510k Number | K803096 |
Device Name: | NARCO TELECARE TRANSDUCER DOME #700-4000 |
Classification | Transducer, Blood-pressure, Extravascular |
Applicant | NARCO SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DRS |
CFR Regulation Number | 870.2850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-12-08 |
Decision Date | 1981-01-13 |