Identity
- Trade Name
- Model 30 Pneumatonometer FDA UDI
- Generic Name
- Ophthalmic tonometer, professional FDA UDI
- Device Name
- AC powered contact tonometer intended for the measurement of intraocular pressure (IOP). The device is indicated for use as a screening /monitoring tool for glaucoma or when increased IOP is suspected. FDA UDI
- Model / Reference
- 16030 FDA UDI
- Description
- AC powered contact tonometer intended for the measurement of intraocular pressure (IOP). The device is indicated for use as a screening /monitoring tool for glaucoma or when increased IOP is suspected. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00812559010955 FDA UDI
- 510(k) Number
- K002395 FDA UDI
- FDA Product Code
- HKX FDA UDI
- GMDN Term
- Ophthalmic tonometer, professional FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.1930 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ophthalmic tonometer, professional
Model 30 Pneumatonometer by Reichert Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K002395 also covers:
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 |
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Manufacturer
- Manufacturer
- Reichert Inc.
Sources (1)
- FDA UDI 7a562774-d349-49f8-81ac-aa24011cc937 35 fields · synced May 30, 2026