The RB 004 Gauge Rail Clamp is an accessory to the NS Series Vacuum/Pressure Gauges. The RB 004 is used to securely mount Gauges with a rear 1/4" NPT thread to rails. For use with…
The RB 004 Gauge Rail Clamp is an accessory to the NS Series Vacuum/Pressure Gauges. The RB 004 is used to securely mount Gauges with a rear 1/4″ NPT thread to rails. For use with Fairfield-style rails only.
Who Else Makes It
Concentrated in Guangdong (3), Fujian (2), Jiangsu (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for RB 004 Gauge Rail Clamp | Listed by | Instrumentation Industries, Incorporated, United States |
| FDA product code | CAP |
| Device type | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.2600 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K081778 |
| Record published | 2016-09-23 |
| Record revised | 2018-07-06 (version 3) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.