The following data is part of a premarket notification filed by Pin Dot Products, Inc. with the FDA for Dynamic Pressure Monitor 2000m And 2000c.
Device ID | K925258 |
510k Number | K925258 |
Device Name: | DYNAMIC PRESSURE MONITOR 2000M AND 2000C |
Classification | System, Pressure Measurement, Intermittent |
Applicant | PIN DOT PRODUCTS, INC. 6001 GROSS POINT RD. Niles, IL 60648 -4027 |
Contact | Michael Silverman |
Correspondent | Michael Silverman PIN DOT PRODUCTS, INC. 6001 GROSS POINT RD. Niles, IL 60648 -4027 |
Product Code | JFC |
CFR Regulation Number | 890.1600 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-10-19 |
Decision Date | 1993-03-09 |