The following data is part of a premarket notification filed by Hospitak, Inc. with the FDA for Low Pressure Alarm For Oxygen Cylinder.
Device ID | K843212 |
510k Number | K843212 |
Device Name: | LOW PRESSURE ALARM FOR OXYGEN CYLINDER |
Classification | Gauge, Gas Pressure, Cylinder/pipeline |
Applicant | HOSPITAK, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BXH |
CFR Regulation Number | 868.2610 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-08-15 |
Decision Date | 1984-09-19 |