The following data is part of a premarket notification filed by Lifeguard Medical Products, Inc. with the FDA for Regulator Flowmeter.
Device ID | K915505 |
510k Number | K915505 |
Device Name: | REGULATOR FLOWMETER |
Classification | Regulator, Pressure, Gas Cylinder |
Applicant | LIFEGUARD MEDICAL PRODUCTS, INC. 6888 HILLSDALE COURT Indianapolis, IN 46250 |
Contact | Craig Trimble |
Correspondent | Craig Trimble LIFEGUARD MEDICAL PRODUCTS, INC. 6888 HILLSDALE COURT Indianapolis, IN 46250 |
Product Code | CAN |
CFR Regulation Number | 868.2700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-12-09 |
Decision Date | 1992-04-22 |