The following data is part of a premarket notification filed by Vickers America Medical Corp. with the FDA for Stretcher Transit Isolater #122.
Device ID | K790657 |
510k Number | K790657 |
Device Name: | STRETCHER TRANSIT ISOLATER #122 |
Classification | Chamber, Patient Isolation |
Applicant | VICKERS AMERICA MEDICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | LGM |
CFR Regulation Number | 880.5450 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-04-05 |
Decision Date | 1979-07-03 |