The following data is part of a premarket notification filed by Kontron Instruments, Inc. with the FDA for Kontron Pulse Oximeter 7840.
Device ID | K873624 |
510k Number | K873624 |
Device Name: | KONTRON PULSE OXIMETER 7840 |
Classification | Oximeter |
Applicant | KONTRON INSTRUMENTS, INC. 9 PLYMOUTH ST. Everett, MA 02149 |
Contact | David Cromwick |
Correspondent | David Cromwick KONTRON INSTRUMENTS, INC. 9 PLYMOUTH ST. Everett, MA 02149 |
Product Code | DQA |
CFR Regulation Number | 870.2700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-08 |
Decision Date | 1988-10-19 |