The following data is part of a premarket notification filed by Y with the FDA for Ivac Model 2080 Electronic Thermometer.
Device ID | K860436 |
510k Number | K860436 |
Device Name: | IVAC MODEL 2080 ELECTRONIC THERMOMETER |
Classification | Thermometer, Electronic, Clinical |
Applicant | Y P.O. BOX 85335 San Diego, CA 92138 -5335 |
Contact | Robert J Bard |
Correspondent | Robert J Bard Y P.O. BOX 85335 San Diego, CA 92138 -5335 |
Product Code | FLL |
CFR Regulation Number | 880.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-02-04 |
Decision Date | 1986-02-12 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
50885403229907 | K860436 | 000 |
10885403229909 | K860436 | 000 |