FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Monarch Platform
K Number: K193534
·
Decision Apr 15, 2020
Classifications
1
FEI Numbers
163
Registration Numbers
163
Same Product Code
238
Applicant Total
4
Review Days
117
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Monarch Platform
- K Number
- K193534
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4680
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Auris Health, Inc.
- Date Received
- December 20, 2019
- Decision Date
- April 15, 2020
- Product Code
- EOQ
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EOQ | Bronchoscope (Flexible Or Rigid) | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EOQ), ordered by most recent decision date.
FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
SmartClip Delivery Catheter (ADR-1715)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
FUJIFILM Ultrasonic Endoscope EB-710US
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
KARL STORZ Flexible Intubation Video Endoscope Sterile (FIVE-S) (0916612)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat