The following data is part of a premarket notification filed by Cavitron Corp. with the FDA for Monitor, Patient, Model Pm-20n.
Device ID | K770736 |
510k Number | K770736 |
Device Name: | MONITOR, PATIENT, MODEL PM-20N |
Classification | Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
Applicant | CAVITRON CORP. 803 N. Front St. Suite 3 McHenry, IL 60050 |
Product Code | CHL |
CFR Regulation Number | 862.1120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-04-21 |
Decision Date | 1977-06-02 |