Product code BXW
- Device name
- Calibrator, Volume, Gas
- Medical specialty
- Anesthesiology
- Device class
- 1
- Regulation number
- 868.1870
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K853848 | RESPIRATORY DIAGNOSTIC EQUIPMENT CALIBRATOR | Medical Graphics Corp. | 1985-12-05 |
| K831758 | FLOW-CALIBRATION MODULE | The Perkin-Elmer Corp. | 1983-07-19 |
| K830898 | SYRINGE 500BC BE #7000 | Instrumentation Industries, Inc. | 1983-05-16 |
| K812765 | DATASCRIBE #DS-40 | Timeter Instrument Corp. | 1981-11-16 |
| K810290 | OHIO CAL-CHEK | Ohio Medical Products | 1981-02-12 |
| K760520 | CALIPERS, MCGAW SKINFOLD | Mcgaw Laboratories | 1976-11-12 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00817136027739 | 5530 3L SYRINGE | HANS RUDOLPH, INC. | 2026-05-01 |
| 00817136027746 | 5530 3L SYRINGE | HANS RUDOLPH, INC. | 2026-05-01 |
| 34250892907421 | Jaeger | Jaeger Medical GmbH | 2025-07-24 |
| 34250892907407 | Jaeger | Jaeger Medical GmbH | 2025-07-24 |
| 04250892907413 | Jaeger | Jaeger Medical GmbH | 2025-07-23 |
| 04250892907888 | Jaeger | Jaeger Medical GmbH | 2025-07-23 |
| 00817081027914 | 3 Liter Aluminum Calibration Syringe w/ Adapter | A-M SYSTEMS, LLC | 2024-11-07 |
| 00817136027685 | 5530 3L SYRINGE | HANS RUDOLPH, INC. | 2024-07-02 |
| 00817136027678 | 5530 3L SYRINGE | HANS RUDOLPH, INC. | 2024-02-13 |
| 00817136027661 | 5570 3L SYRINGE | HANS RUDOLPH, INC. | 2023-11-08 |
| 00817136027654 | 5570 3L SYRINGE | HANS RUDOLPH, INC. | 2023-08-21 |
| 00817136027647 | 5570 3L SYRINGE | HANS RUDOLPH, INC. | 2023-08-17 |
| 00857175006067 | 3L Calibration Syringe | VECTRACOR INC | 2023-06-07 |
| 00817081027594 | Syringe, Calibration, Adj. Vol., Aluminum | A-M SYSTEMS, LLC | 2023-05-17 |
| 00817136027043 | 5540 1L SYRINGE | HANS RUDOLPH, INC. | 2023-01-05 |
| 00817136027036 | 5570 3L SYRINGE | HANS RUDOLPH, INC. | 2022-12-16 |
| 00817136026909 | 5530 3L SYRINGE | HANS RUDOLPH, INC. | 2022-08-08 |
| 05099169414846 | Compact | VITALOGRAPH (IRELAND) LIMITED | 2017-11-15 |
| 15099169360201 | Precision Syringe | VITALOGRAPH (IRELAND) LIMITED | 2016-12-09 |
| 15099169360232 | Precision Syringe | VITALOGRAPH (IRELAND) LIMITED | 2016-12-09 |
| 15099169360225 | Precision Syringe | VITALOGRAPH (IRELAND) LIMITED | 2016-12-09 |
| 15099169204086 | Precision Syringe | VITALOGRAPH (IRELAND) LIMITED | 2016-12-09 |
| 05099169439979 | PFM | VITALOGRAPH (IRELAND) LIMITED | 2016-12-08 |
| 05099169439931 | PFM | VITALOGRAPH (IRELAND) LIMITED | 2016-12-08 |
| 05099169439917 | PFM | VITALOGRAPH (IRELAND) LIMITED | 2016-12-08 |
| 05099169439849 | PFM | VITALOGRAPH (IRELAND) LIMITED | 2016-12-08 |
| 05099169439832 | PFM | VITALOGRAPH (IRELAND) LIMITED | 2016-12-08 |
| 05099169439504 | PFM | VITALOGRAPH (IRELAND) LIMITED | 2016-12-08 |
| 05099169439030 | PFM | VITALOGRAPH (IRELAND) LIMITED | 2016-12-08 |
| 05099169439009 | PFM | VITALOGRAPH (IRELAND) LIMITED | 2016-12-06 |