Product code JEJ
- Device name
- Tubing, Instrumentation, Bronchoscope (Brush Sheath A/O Aspirating)
- Medical specialty
- Ear, Nose, Throat
- Device class
- 2
- Regulation number
- 874.4680
- Review panel
- EN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- Definition
- If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|
| K874705 | EASY-TEST AMYLASE (AMYL), ITEM NUMBER 19019 | Em Diagnostic Systems, Inc. | 1987-12-22 |
| K821514 | TECHNICON RA-1000 SYS, ANALYTES III | Technicon Instruments Corp. | 1982-05-10 |