The following data is part of a premarket notification filed by Talley Group Ltd. with the FDA for Oxford Pressure Monitor/talley Pressure Monitor.
Device ID | K914776 |
510k Number | K914776 |
Device Name: | OXFORD PRESSURE MONITOR/TALLEY PRESSURE MONITOR |
Classification | System, Pressure Measurement, Intermittent |
Applicant | TALLEY GROUP LTD. 815 TERMINAL RD. Lansing, MI 48906 |
Contact | Van Dyke |
Correspondent | Van Dyke TALLEY GROUP LTD. 815 TERMINAL RD. Lansing, MI 48906 |
Product Code | JFC |
CFR Regulation Number | 890.1600 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-10-23 |
Decision Date | 1991-12-19 |