Disposa-Spec
510(k) K840593
Disposa-Spec is a medical device (FDA Class I; FDA product code ERA, Otoscope) made by Plasti-Products, Inc., cleared under FDA 510(k) K840593 on 13 Jul 1984, 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 | NumberK840593 | Date13 Jul 1984 | StatusActive |
Official records
- FDA 510(k) database K840593
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- Withdrawn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).
- RI-SCOPE (S) by Rudolf Riester GmbH & Co. KG
- MedRx Video Otoscope by Medrx, Inc.
- 1-100 UNIVERSAL SET OTOSCOPE & LARYNX EXPLORATON B by Artiberia
- WELCH ALLYN OTOSCOPE by Welch Allyn, Inc.
- TYMPANOSCOPE by JEDMED Instrument Company
- OTOVIEW TELESCOPIC OTOSCOPES by Smith & Nephew, Inc.
- SPECULUM, ENT (S3) by Pedia Pals, Inc.
- AUDIOSCOPE #23000 W/71123 CHARGING STAND by Welch Allyn, Inc.
- STANDARD by Rudolf Riester GmbH & Co. KG
- DR. DEDO'S FAMILY EAR EXAMINATION KIT by Panex Corp.