Product code EWE
- Device name
- Protector, Hearing (Circumaural)
- Medical specialty
- Unknown
- Device class
- U
- Review panel
- EN
- 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 |
|---|---|---|---|
| K935160 | MINIMUFFS | Natus Medical, Inc. | 1995-02-09 |
Related GUDID Devices#
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|---|---|---|---|
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| 00628725095318 | Micro Minimuffs | CHS USA Inc. | 2026-01-07 |
| 50628725095290 | MiniMuffs | Canadian Hospital Specialties Limited | 2025-04-11 |
| 00628725095295 | MiniMuffs | Canadian Hospital Specialties Limited | 2025-04-11 |
| 10194484320741 | Condor | GRAINGER INTERNATIONAL, INC. | 2024-09-20 |
| 20194484320748 | Condor | GRAINGER INTERNATIONAL, INC. | 2024-09-20 |
| 20194484320731 | Condor | GRAINGER INTERNATIONAL, INC. | 2024-09-20 |
| 10194484320734 | Condor | GRAINGER INTERNATIONAL, INC. | 2024-09-20 |
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| 00860008980793 | DREAMIES | NEATCAP MEDICAL LLC | 2022-12-08 |
| 00860008980786 | DREAMIES | NEATCAP MEDICAL LLC | 2022-12-08 |
| 00860008980779 | DREAMIES | NEATCAP MEDICAL LLC | 2022-12-08 |
| 00860008980762 | DREAMIES | NEATCAP MEDICAL LLC | 2022-12-08 |
| 00860008980755 | DREAMIES | NEATCAP MEDICAL LLC | 2022-12-08 |
| 00860008980731 | DREAMIES T-M | NEATCAP MEDICAL LLC | 2022-12-08 |
| 00860008980724 | DREAMIES T-M | NEATCAP MEDICAL LLC | 2022-12-08 |
| 00860008980717 | DREAMIES T-M | NEATCAP MEDICAL LLC | 2022-12-08 |
| 00860008980700 | DREAMIES T-M | NEATCAP MEDICAL LLC | 2022-12-08 |
| 00033552000242 | Howard Leight by Honeywell | SPERIAN HEARING PROTECTION, LLC | 2020-09-22 |
| 00033552022053 | Howard Leight by Honeywell | SPERIAN HEARING PROTECTION, LLC | 2020-09-21 |
| 00033552025221 | Howard Leight | SPERIAN HEARING PROTECTION, LLC | 2020-07-31 |
| 00033552022312 | Howard Leight | SPERIAN HEARING PROTECTION, LLC | 2020-07-31 |
| 00033552019022 | Howard Leight | SPERIAN HEARING PROTECTION, LLC | 2020-07-31 |
| 07312550119945 | Howard Leight | SPERIAN HEARING PROTECTION, LLC | 2020-07-31 |
| 00033552015307 | Howard Leight | SPERIAN HEARING PROTECTION, LLC | 2020-07-31 |
| 00033552015260 | Howard Leight | SPERIAN HEARING PROTECTION, LLC | 2020-07-31 |
| 10033552015267 | Howard Leight | SPERIAN HEARING PROTECTION, LLC | 2020-07-31 |
| 10033552015304 | Howard Leight | SPERIAN HEARING PROTECTION, LLC | 2020-07-31 |
| 10851253007554 | Uline Earmuff - Hi-Vis Lime | ULINE, INC. | 2019-02-07 |
| 10851253007547 | Uline Earmuff - Black | ULINE, INC. | 2019-02-07 |