BXHClass I
Gauge, Gas Pressure, Cylinder/Pipeline
21 CFR 868.2610 / Anesthesiology
BXH is the FDA product code for Gauge, Gas Pressure, Cylinder/Pipeline, a class I device type, regulated under 21 CFR 868.2610. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and one recall.
Classification record
- Product code
- BXH
- Device name
- Gauge, Gas Pressure, Cylinder/Pipeline
- Regulation
- 21 CFR 868.2610
- Device class
- Class I
- Review panel
- Anesthesiology
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 4
- Ingested recalls
- 1
Clearances, product code BXH
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1984 | 1 |
| 1985 | 1 |
| 1994 | 1 |
Applicants with the most clearances
Product code BXH| Applicant | Clearances |
|---|---|
| B & F Medical Products, Inc. | 1 |
| Dynatech Cryomedical Co. | 1 |
| Erie Medical | 1 |
| Hospitak, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Accutron Inc
- Besmed Health Business Corporation
- Create Biotech Co., Ltd.
- Fisher & Paykel Healthcare, Inc.
- Gentec (Shanghai) Corporation
- Heuer International (A division of GST Corporation Limited)
- Megasan Medikal Gaz Sistemleri Tibbi Alet ve Cihazlar San. Tic. A. S.
- MPS Project
- Precision Fluidics Division Parker Hannifin Corp.
- Ruian Sunnyworld International Trade Co.,Ltd
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
