The following data is part of a premarket notification filed by Precision Medical, Inc. with the FDA for Precision Medical Eliminator.
Device ID | K902917 |
510k Number | K902917 |
Device Name: | PRECISION MEDICAL ELIMINATOR |
Classification | Flowmeter, Calibration, Gas |
Applicant | PRECISION MEDICAL, INC. 300 HELD DR. Northampton, PA 18067 |
Contact | John R Selady |
Correspondent | John R Selady PRECISION MEDICAL, INC. 300 HELD DR. Northampton, PA 18067 |
Product Code | BXY |
CFR Regulation Number | 868.2350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-07-03 |
Decision Date | 1990-07-23 |