Videotoscope
510(k) K943916
Videotoscope is a Class I device made by Welch Allyn, Inc., cleared under FDA 510(k) K943916 on 25 Aug 1994, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK943916 | Date25 Aug 1994 | StatusActive |
Official records
- FDA 510(k) database K943916
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- ERA
- Device class
- Class I
- Regulation
- 21 CFR Part 874.4770
- Advisory committee
- Ear, Nose, Throat
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code ERA (Otoscope).
- IMEDGE VIDEO OSTOSCOPE (ANALOG) by Introspect, Inc.
- HARMONICA 11205 by INVENTIS SRL
- BETA X Otoscope 4.2 x B-131.28.330 by Heine Optotechnik GmbH & Co. KG
- CLARUS MODEL 2240 SEMI-RIGID OTOSCOPE by Clarus Medical Systems, Inc.
- P.P.P. TREATMENT CABINET by Precision Professional Products
- VIDEO SCOPE SYSTEM (OTOSCOPE) by JEDMED Instrument Company
- AIO HD OTOSCOPE by Blue Focus
- OPTUS OTOSCOPES by Optus, Inc.
- TytoPro G2 900-00002-062 by TYTO CARE LTD
- OTOSCOPE by Truphatek, Ltd.