The following data is part of a premarket notification filed by Vitalograph Ltd. with the FDA for Emergency Aspirator.
Device ID | K833785 |
510k Number | K833785 |
Device Name: | EMERGENCY ASPIRATOR |
Classification | Pump, Portable, Aspiration (manual Or Powered) |
Applicant | VITALOGRAPH LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BTA |
CFR Regulation Number | 878.4780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-10-28 |
Decision Date | 1983-12-22 |