BXW · Calibrator, Volume, Gas
Anesthesiology · 21 CFR 868.1870 · Class 1
Overview
| Product Code | BXW |
|---|---|
| Device Name | Calibrator, Volume, Gas |
| Regulation | 21 CFR 868.1870 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
Identification
A gas volume calibrator is a device that is intended for medical purposes and that is used to calibrate the output of gas volume measurement instruments by delivering a known gas volume.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
Recent Cleared Devices (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K853848 | RESPIRATORY DIAGNOSTIC EQUIPMENT CALIBRATOR | Medical Graphics Corp. | Dec 5, 1985 | SESE |
| K831758 | FLOW-CALIBRATION MODULE | The Perkin-Elmer Corp. | Jul 19, 1983 | SESE |
| K830898 | SYRINGE 500BC BE #7000 | Instrumentation Industries, Inc. | May 16, 1983 | SESE |
| K812765 | DATASCRIBE #DS-40 | Timeter Instrument Corp. | Nov 16, 1981 | SESE |
| K810290 | OHIO CAL-CHEK | Ohio Medical Products | Feb 12, 1981 | SESE |
| K760520 | CALIPERS, MCGAW SKINFOLD | Mcgaw Laboratories | Nov 12, 1976 | SESE |
Top Applicants
- Instrumentation Industries, Inc. — 1 clearance
- Mcgaw Laboratories — 1 clearance
- Medical Graphics Corp. — 1 clearance
- Ohio Medical Products — 1 clearance
- The Perkin-Elmer Corp. — 1 clearance
