The following data is part of a premarket notification filed by Oxequip Health Ind. with the FDA for Oxequip Model 34 Med*star Oxygen Monitor.
Device ID | K792356 |
510k Number | K792356 |
Device Name: | OXEQUIP MODEL 34 MED*STAR OXYGEN MONITOR |
Classification | Analyzer, Gas, Oxygen, Gaseous-phase |
Applicant | OXEQUIP HEALTH IND. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CCL |
CFR Regulation Number | 868.1720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-11-21 |
Decision Date | 1979-12-04 |