Welch Allyn, Inc.
Welch Allyn 3.5 V Halogen HPX Diagnostic Desk Set including PanOptic Ophthalmoscope with Cobalt-Blue Filter and Corneal Viewing Lens (#11820), MacroView Otoscope (#23810), Rechargeable…
Welch Allyn 3.5 V Halogen HPX Diagnostic Desk Set including PanOptic Ophthalmoscope with Cobalt-Blue Filter and Corneal Viewing Lens (#11820), MacroView Otoscope (#23810), Rechargeable 60-Minute Power Handle(s), Universal Desk Charger; 100-240 V, 50-60 Hz AC, 2 Ni ckel-Cadmium (#72200) Batteries; IEC Plug Type-B
Who Else Makes It
Concentrated in Jiangsu (5), Beijing (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Wuxi Zontai Int’l Corporation Ltd. | Wuxi | Jiangsu | Contract manufacturer | 22 |
| Beijing Hongdee Corporation | Beijing | Beijing | Private-label distributor | 43 |
| Taizhou City K&W International Trade Co., Ltd. | Jiangyan | Jiangsu | Repacker / relabeller | 38 |
| Lianyungang Tiannuo Optical Instrument Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 31 |
| 66 Vision Tech Co., Ltd. | Suzhou | Jiangsu | Private-label distributor | 24 |
| Suzhou Raish Meditech Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 4 |
Record
| Listed by | Welch Allyn, Inc., United States |
|---|---|
| FDA product code | HLS |
| Device type | Exophthalmometer |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1270 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K771900 |
| Record published | 2023-08-17 |
| Record revised | 2022-06-27 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
| Distribution end date | 2023-10-04 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 901087 | In distribution | |
| 901001 | In distribution | |
| 901087 | In distribution | |
| 901001 | In distribution | |
| 901001 | In distribution | |
| 901001 | In distribution | |
| 901087 | In distribution | |
| 901087 | In distribution | |
| 901001 | In distribution | |
| 901087 | In distribution | |
| 901087 | In distribution | |
| 901001 | In distribution | |
| 901001 | In distribution | |
| 901087 | In distribution | |
| 901087 | In distribution | |
| 901086 | In distribution | |
| 901087 | In distribution | |
| 901087 | In distribution | |
| 901122 | In distribution | |
| 901087 | In distribution | |
| 901087 | In distribution | |
| 901087 | In distribution | |
| 901001 | In distribution | |
| 901001 | In distribution | |
| 901088 | In distribution | |
| 901001 | In distribution | |
| 901087 | In distribution | |
| 901001 | In distribution | |
| 901088 | In distribution | |
| 901088 | In distribution | |
| 901087 | In distribution | |
| 901001 | In distribution | |
| 901087 | In distribution | |
| 901001 | In distribution | |
| 901087 | In distribution | |
| 901087 | In distribution | |
| 901087 | In distribution | |
| 901087 | In distribution | |
| 901087 | In distribution | |
| 901001 | In distribution | |
| 901087 | In distribution | |
| 901001 | In distribution | |
| 901088 | In distribution | |
| 901001 | In distribution | |
| 901088 | In distribution | |
| 901001 | In distribution | |
| 901087 | In distribution | |
| 901001 | In distribution | |
| 901087 | In distribution | |
| 901088 | In distribution | |
| 901087 | In distribution | |
| 901001 | In distribution | |
| 901087 | In distribution | |
| 901087 | In distribution | |
| 901088 | In distribution | |
| 901001 | In distribution | |
| 901087 | Withdrawn | |
| 901087 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tiannuo / Tnmed | Lianyungang Tiannuo Optical Instrument Co., Ltd. | 2 |
| Luedde Exophthalmometer | Gulden Ophthalmics | 1 |
| Mirror Exophthalmometer acc. to Naugle | Oculus Optikgeräte Gesellschaft mit beschränkter Haftung | 1 |
| Mirror Exophthalmometer acc. to Hertel | Oculus Optikgeräte Gesellschaft mit beschränkter Haftung | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K771900 | 1977-11-09 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.