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FDA 510(k), K010998, LANGHAM OCULAR BLOOD FLOW (OBF) TONOGRAPH/TONOMETER MODEL 201
FDA 510(k), K010998, LANGHAM OCULAR BLOOD FLOW (OBF) TONOGRAPH/TONOMETER MODEL 201
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510(K) Number: K010998
Device Name: LANGHAM OCULAR BLOOD FLOW (OBF) TONOGRAPH/TONOMETER MODEL 201
Manufacturer: MAURICE E LANGHAM
Device Classification Name: Tonometer, Ac-Powered
Regulation Number: HKX
Classification Product Code: 04/03/2001
Date Received: 06/27/2001
Decision Date: SE - With Limitations (SESU)
Regulation Medical Specialty: Ophthalmic
Device Name: LANGHAM OCULAR BLOOD FLOW (OBF) TONOGRAPH/TONOMETER MODEL 201
Manufacturer: MAURICE E LANGHAM
Device Classification Name: Tonometer, Ac-Powered
Regulation Number: HKX
Classification Product Code: 04/03/2001
Date Received: 06/27/2001
Decision Date: SE - With Limitations (SESU)
Regulation Medical Specialty: Ophthalmic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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