The following data is part of a premarket notification filed by Research Development Corp. with the FDA for Ring-orifice, Turbulent Flow Pneumot.
Device ID | K791730 |
510k Number | K791730 |
Device Name: | RING-ORIFICE, TURBULENT FLOW PNEUMOT |
Classification | Pneumotachometer |
Applicant | RESEARCH DEVELOPMENT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JAX |
CFR Regulation Number | 868.2550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-08-28 |
Decision Date | 1979-11-16 |