The following data is part of a premarket notification filed by Pro-tech, Inc. with the FDA for Plm Sensor, Model Plm1.
Device ID | K940014 |
510k Number | K940014 |
Device Name: | PLM SENSOR, MODEL PLM1 |
Classification | Monitor, Breathing Frequency |
Applicant | PRO-TECH, INC. P.O. BOX 2165 17710-134TH AVENUE N.E. Woodinville, WA 98072 |
Contact | Randy Carruthers |
Correspondent | Randy Carruthers PRO-TECH, INC. P.O. BOX 2165 17710-134TH AVENUE N.E. Woodinville, WA 98072 |
Product Code | BZQ |
CFR Regulation Number | 868.2375 [🔎] |
Decision | Se Subject To Tracking Reg (ST) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-01-04 |
Decision Date | 1994-11-10 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00606959021723 | K940014 | 000 |
00606959011083 | K940014 | 000 |
00606959011069 | K940014 | 000 |
00606959011052 | K940014 | 000 |
00606959039681 | K940014 | 000 |
00606959039674 | K940014 | 000 |
00606959038929 | K940014 | 000 |