Product code BXY
- Device name
- Flowmeter, Calibration, Gas
- Medical specialty
- Anesthesiology
- Device class
- 1
- Regulation number
- 868.2350
- 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 |
|---|---|---|---|
| K953506 | WESTMED RESPIRATORY LUER ADAPTOR | Westmed Intl. | 1995-09-15 |
| K902916 | PRECISION MEDICAL NEB BLOCK | Precision Medical, Inc. | 1990-07-23 |
| K902917 | PRECISION MEDICAL ELIMINATOR | Precision Medical, Inc. | 1990-07-23 |
| K863510 | OXY-OFF(TM) | B&B Medical Technologies, Inc. | 1986-10-22 |
| K860516 | LSP MINILATOR | Life Support Products, Inc. | 1986-02-21 |
| K851460 | NEW CONNECTOR & COVER FOR TELECTRONICS 8MM UNIPOLA | Telectronics, Inc. | 1985-05-10 |
| K781523 | PFT GASES | Gardner Cryogenics | 1978-12-01 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00848530108656 | Repair Parts | SUNSET HEALTHCARE SOLUTIONS, INC. | 2026-03-17 |
| 00850027043845 | Precision Medical Inc. | Precision Medical, Inc. | 2026-02-25 |
| 10848530105508 | REPAIR PARTS | SUNSET HEALTHCARE SOLUTIONS, INC. | 2025-08-27 |
| 20848530105208 | REPAIR PARTS | SUNSET HEALTHCARE SOLUTIONS, INC. | 2025-08-27 |
| 00848530105501 | REPAIR PARTS | SUNSET HEALTHCARE SOLUTIONS, INC. | 2025-08-27 |
| 00848530105204 | REPAIR PARTS | SUNSET HEALTHCARE SOLUTIONS, INC. | 2025-08-27 |
| 00026072022474 | EM | Allied Medical, LLC | 2024-09-16 |
| 00026072022450 | EM | Allied Medical, LLC | 2024-09-16 |
| 00026072022443 | EM | Allied Medical, LLC | 2024-09-16 |
| 00026072022467 | EM | Allied Medical, LLC | 2024-09-16 |
| 00026072022481 | EM | Allied Medical, LLC | 2024-09-16 |
| B366U1RH1011 | R-FLOWMETER | Ecleris | 2024-08-16 |
| 00817770025863 | Manifold | MAXTEC, LLC | 2024-08-14 |
| 00817770025870 | Manifold | MAXTEC, LLC | 2024-08-14 |
| 00817770025955 | Manifold | MAXTEC, LLC | 2024-08-14 |
| 00848530020019 | CPAP Accesory | SUNSET HEALTHCARE SOLUTIONS, INC. | 2024-06-17 |
| 00026072022511 | EM | Allied Medical, LLC | 2024-05-28 |
| 07640214642868 | FlowMeter F2 | IMT Analytics AG | 2023-09-18 |
| 07640214642851 | FlowMeter F1 | IMT Analytics AG | 2023-09-18 |
| 07640214642844 | FlowMeter F2 | IMT Analytics AG | 2023-09-18 |
| 07640214642837 | FlowMeter F1 | IMT Analytics AG | 2023-09-18 |
| 07640214642707 | Flow Analyzer PF-300 PRO | IMT Analytics AG | 2022-11-17 |
| 07640214642462 | Flow Analyzer PF-302 | IMT Analytics AG | 2022-11-17 |
| 07640214642455 | Flow Analyzer PF-301 | IMT Analytics AG | 2022-11-17 |
| 07640214642448 | Flow Analyzer PF-300 | IMT Analytics AG | 2022-11-17 |
| 07640214642417 | CITREX H5 | IMT Analytics AG | 2022-11-17 |
| 07640214642400 | CITREX H4 | IMT Analytics AG | 2022-11-17 |
| 16975816240005 | Bawmed | SUZHOU BAW MEDTECH LTD | 2022-11-03 |
| 00840117318694 | Resp-O2 Portable Oxygen Liter Meters | Dynarex Corporation | 2021-04-22 |
| 00709078008986 | Respiratory Adaptor W/Luer Port, Cap | WESTMED, INC. | 2020-08-31 |