The following data is part of a premarket notification filed by Thomas Industries with the FDA for Nebulizer Pump, Powered Model 1180.
Device ID | K925011 |
510k Number | K925011 |
Device Name: | NEBULIZER PUMP, POWERED MODEL 1180 |
Classification | Compressor, Air, Portable |
Applicant | THOMAS INDUSTRIES 1419 ILLINOIS AVE. Sheboygan, WI 53082 -0029 |
Contact | Dan Pfister |
Correspondent | Dan Pfister THOMAS INDUSTRIES 1419 ILLINOIS AVE. Sheboygan, WI 53082 -0029 |
Product Code | BTI |
CFR Regulation Number | 868.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-10-02 |
Decision Date | 1994-01-12 |