BOUCHER DEGROOT HEAD POSITIONING GLASSES, MODEL 8080

• K Number: K000544
• Device Name: BOUCHER DEGROOT HEAD POSITIONING GLASSES, MODEL 8080
• Manufacturer: LABTICIAN OPHTHALMICS, INC.
• Date Cleared: 2000-03-09 ( 20 days)
• Product Code: HJX
• Regulation Number: 886.5810

Intended Use

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Device Description

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Predicate Devices

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Reference Devices

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AI/ML (Artificial Intelligence / Machine Learning)

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Therapeutic

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Diagnostic

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SaMD (Software as a Medical Device)

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IVD (In Vitro Diagnostic)

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PCCP (Predetermined Change Control Plan) Authorized

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Overview

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Regulation Number and Section

§ 886.5810 Ophthalmic prism reader.

(a)
Identification. An ophthalmic prism reader is a device intended for use by a patient who is in a supine position to change the angle of print to aid reading.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

Summary

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