The following data is part of a premarket notification filed by G & W Applied Science Laboratories with the FDA for S/d 600 Sphygmomanometer And Pulsemeter.
Device ID | K780805 |
510k Number | K780805 |
Device Name: | S/D 600 SPHYGMOMANOMETER AND PULSEMETER |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | G & W APPLIED SCIENCE LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-05-11 |
Decision Date | 1978-06-06 |