The following data is part of a premarket notification filed by American Hospital Supply Corp. with the FDA for Monitor/vital Signs Tray.
Device ID | K811915 |
510k Number | K811915 |
Device Name: | MONITOR/VITAL SIGNS TRAY |
Classification | Gown, Examination |
Applicant | AMERICAN HOSPITAL SUPPLY CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FME |
CFR Regulation Number | 880.6265 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-07-01 |
Decision Date | 1981-07-28 |