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FDA 510(k)

FRAGMATOME MODEL 820

K-Number: K771644 · 1977-09-26

ApplicantBerkeley Bio-Engineering
Decision Date1977-09-26
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

FRAGMATOME MODEL 820 is the device name listed in this FDA 510(k) record. The listed applicant is Berkeley Bio-Engineering. It received FDA 510(k) clearance on 1977-09-26 under 510(k) number K771644. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FRAGMATOME MODEL 820?

FRAGMATOME MODEL 820 is a medical device that received FDA 510(k) clearance on 1977-09-26. The listed applicant is Berkeley Bio-Engineering. The 510(k) number is K771644.

When did FRAGMATOME MODEL 820 receive FDA 510(k) clearance?

FRAGMATOME MODEL 820 received FDA 510(k) clearance on 1977-09-26, under 510(k) number K771644.

Who is the listed applicant for FRAGMATOME MODEL 820?

The FDA 510(k) record lists Berkeley Bio-Engineering as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FRAGMATOME MODEL 820?

The FDA product code for FRAGMATOME MODEL 820 is HQC.

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Other records listing Berkeley Bio-Engineering as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K790645ENDOTOMEK771711BIOTOMEK770292MONITOR, FETAL HEART, MODEL 1980

Related Devices (Code: HQC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261264Stellaris Elite™ vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite™ Pack (SE5423); 23 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423B); 25 ga. Posterior Elite™ Pack (SE5425); 25 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5425B); 27 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5427B); 23 ga. Bi-Blade™+ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423BB+); 25 ga. Bi-Blade™+Bausch and LombK252052Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)Bausch and Lomb, IncorporatedK250501System SophiThis AGK243395MICOR 700 with Auto I/ACarl Zeiss Meditec Cataract Technology, Inc.K242801MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)Carl Zeiss Meditec Cataract Technology, Inc.K240169Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)Bausch and Lomb, Incorporated

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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