Identity
- Trade Name
- Adstation™ FDA UDI
- Generic Name
- Ophthalmic/otologic diagnostic set FDA UDI
- Device Name
- Adstation OtoX/Oph2L,w/Spec/ThroatL/750W FDA UDI
- Model / Reference
- 56102B-36L7 FDA UDI
- Description
- Adstation OtoX/Oph2L,w/Spec/ThroatL/750W FDA UDI
Identifiers
- Catalog Number
- 56102B-36L7 FDA UDI
- Primary DI / UDI-DI
- 00634782077570 FDA UDI
- 510(k) Number
- K950914 FDA UDI
- FDA Product Code
- HLJ FDA UDI
- GMDN Term
- Ophthalmic/otologic diagnostic set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.1570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ophthalmic/otologic diagnostic set
Adstation™ by American Diagnostic Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic/otologic diagnostic set.
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class I
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class I
- May-ophthalmoscope head XL 3.5 V, — Rudolf Riester GmbH & Co. KG · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- MEDLINE — MEDLINE INDUSTRIES, INC. · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
Cleared under the same submission
K950914 also covers:
- Adstation™ — American Diagnostic Corporation
- Adstation™ — American Diagnostic Corporation
- Adstation™ — American Diagnostic Corporation
- Adstation™ — American Diagnostic Corporation
- Adstation™ — American Diagnostic Corporation
- Adstation™ — American Diagnostic Corporation
- Adstation™ — American Diagnostic Corporation
- Adstation™ — American Diagnostic Corporation
- Adstation™ — American Diagnostic Corporation
- Adstation™ — American Diagnostic Corporation
- Adstation™ — American Diagnostic Corporation
- Adstation™ — American Diagnostic Corporation
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- American Diagnostic Corporation
Sources (1)
- FDA UDI cca51bf0-92ca-4429-a091-0880c0e387ea 37 fields · synced May 30, 2026