Product code HOO— Ophthalmic

FDA has cleared 6 devices under product code HOO between 1983 and 1994, filed by 6 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 19941 clearance
• 19931 clearance
• 19871 clearance
• 19862 clearances
• 19831 clearance

• Welch Allyn, Inc.1 clearance
• Richmond Products, Inc.1 clearance
• Marco Ophthalmic, Inc.1 clearance
• Keeler Instruments, Inc.1 clearance
• CooperVision, Inc.1 clearance
• Bio-Rad1 clearance

• K941723 — WELCH ALLYN GLAUCOMA DETECTORWelch Allyn, Inc.·1994-06-06
• K930448 — MARCO PROJECTION PERIMETERMarco Ophthalmic, Inc.·1993-06-21
• K873912 — RICHMOND VISUAL FIELD SCREENERRichmond Products, Inc.·1987-11-02
• K864467 — HENSON - HAMBLIN CFS 2000 CENTRAL FIELD SCREENKeeler Instruments, Inc.·1986-12-15
• K860115 — DIGILAB CAMBRIDGE PERIMETERBio-Rad·1986-02-27
• K832800 — AUTOMATIC TANGENT SCREEN 50CooperVision, Inc.·1983-09-29