Product code BTK
- Device name
- Strap, Head, Gas Mask
- Medical specialty
- Anesthesiology
- Device class
- 1
- Regulation number
- 868.5560
- 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 |
|---|---|---|---|
| K944949 | GENERAL ANESTHESIA SYSTEM | Vital Signs, Inc. | 1994-11-14 |
| K914335 | STRAP, HEAD, GAS MASK | Vital Signs, Inc. | 1992-04-02 |
| K854537 | HEADSTRAP | Life Design Systems, Inc. | 1985-12-03 |
| K853573 | MEDIPART FACE MASK HEADSTRAP MP-9100 | Medipart Jerry Alexander | 1985-10-29 |
| K831008 | HEAD STRAP | Medovations, Inc. | 1983-05-09 |
| K810991 | HEADSTRAP | Respironics, Inc. | 1981-04-29 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10889483606827 | AirLife™ | AIRLIFE | 2025-03-03 |
| 10889483606841 | AirLife™ | AIRLIFE | 2025-03-03 |
| 10889483606858 | AirLife™ | AIRLIFE | 2025-03-03 |
| 10889483606865 | AirLife™ | AIRLIFE | 2025-03-03 |
| 10889483606872 | AirLife™ | AIRLIFE | 2025-03-03 |
| 10889483606896 | AirLife™ | AIRLIFE | 2025-03-03 |
| 10889483606919 | AirLife™ | AIRLIFE | 2025-03-03 |
| 00848530081607 | Chin Strap | SUNSET HEALTHCARE SOLUTIONS, INC. | 2024-06-19 |
| 00848530080389 | Chin Strap | SUNSET HEALTHCARE SOLUTIONS, INC. | 2024-06-19 |
| 00023601071354 | Carex Health Brands | Drive Devilbiss Healthcare | 2024-02-06 |
| 00023601071347 | Carex Health Brands | Drive Devilbiss Healthcare | 2024-02-06 |
| 00023601071330 | Carex Health Brands | Drive Devilbiss Healthcare | 2024-02-06 |
| 00023601071323 | Carex | Drive Devilbiss Healthcare | 2023-11-02 |
| 08058323014282 | Underarm Straps | Intersurgical Incorporated | 2023-06-19 |
| 14026704743909 | RUSCH | TELEFLEX INCORPORATED | 2023-04-04 |
| 00612649191348 | FACE MASK HEADSTRAP | King Systems Corporation | 2022-12-08 |
| 00612649191331 | FACE MASK HEADSTRAP | King Systems Corporation | 2022-12-08 |
| 14026704744296 | RUSCH | TELEFLEX INCORPORATED | 2022-12-02 |
| H66860701551 | Mizzy Comfort Cushion | Keystone Industries | 2022-11-30 |
| 16931918175348 | Alleset | GRI Medical & Electronic Technology Co., Ltd. | 2022-11-27 |
| 14026704744302 | RUSCH | TELEFLEX INCORPORATED | 2022-11-18 |
| 14026704641533 | RUSCH | TELEFLEX INCORPORATED | 2019-04-24 |
| 14026704641526 | RUSCH | TELEFLEX INCORPORATED | 2019-04-24 |
| 14026704640482 | HUDSON RCI | TELEFLEX INCORPORATED | 2019-04-23 |
| 14026704640475 | HUDSON RCI | TELEFLEX INCORPORATED | 2019-04-23 |
| 14026704640468 | HUDSON RCI | TELEFLEX INCORPORATED | 2019-04-23 |
| 00848530040574 | Sunset Ruby Style Chin Strap - Small | SUNSET HEALTHCARE SOLUTIONS, INC. | 2018-09-17 |
| 00848530040581 | Sunset Ruby Style Chin Strap - Medium | SUNSET HEALTHCARE SOLUTIONS, INC. | 2018-09-17 |
| 00848530040598 | Sunset Ruby Style Chin Strap - Large | SUNSET HEALTHCARE SOLUTIONS, INC. | 2018-09-17 |
| 00848530081485 | Sunset Halo Style Chinstrap | SUNSET HEALTHCARE SOLUTIONS, INC. | 2018-09-17 |