The following data is part of a premarket notification filed by Narco Air-shields with the FDA for Ambu Universal Suction Pump.
Device ID | K792592 |
510k Number | K792592 |
Device Name: | AMBU UNIVERSAL SUCTION PUMP |
Classification | Apparatus, Suction, Ward Use, Portable, Ac-powered |
Applicant | NARCO AIR-SHIELDS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JCX |
CFR Regulation Number | 878.4780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-12-17 |
Decision Date | 1980-01-11 |