The following data is part of a premarket notification filed by Dhd Medical Products Div. Diemolding Corp. with the FDA for Inspiratory Force Mont Kit/manifold/meter/tubing.
Device ID | K873498 |
510k Number | K873498 |
Device Name: | INSPIRATORY FORCE MONT KIT/MANIFOLD/METER/TUBING |
Classification | Meter, Airway Pressure (inspiratory Force) |
Applicant | DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP. DIVISION OF DIEMOLDING CORP. Canastota, NY 13032 |
Contact | Jean Wallace |
Correspondent | Jean Wallace DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP. DIVISION OF DIEMOLDING CORP. Canastota, NY 13032 |
Product Code | BXR |
CFR Regulation Number | 868.1780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-08-31 |
Decision Date | 1988-03-09 |