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FDA 510(k)

EPA AUTOMATED INFUSION POLE

K-Number: K832997 · 1983-10-04

ApplicantMiami Eye Technology, Inc.
Decision Date1983-10-04
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

EPA AUTOMATED INFUSION POLE is the device name listed in this FDA 510(k) record. The listed applicant is Miami Eye Technology, Inc.. It received FDA 510(k) clearance on 1983-10-04 under 510(k) number K832997. 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 EPA AUTOMATED INFUSION POLE?

EPA AUTOMATED INFUSION POLE is a medical device that received FDA 510(k) clearance on 1983-10-04. The listed applicant is Miami Eye Technology, Inc.. The 510(k) number is K832997.

When did EPA AUTOMATED INFUSION POLE receive FDA 510(k) clearance?

EPA AUTOMATED INFUSION POLE received FDA 510(k) clearance on 1983-10-04, under 510(k) number K832997.

Who is the listed applicant for EPA AUTOMATED INFUSION POLE?

The FDA 510(k) record lists Miami Eye Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EPA AUTOMATED INFUSION POLE?

The FDA product code for EPA AUTOMATED INFUSION POLE is HQC.

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Other records listing Miami Eye Technology, Inc. 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.

K841101CLAYMAN-PAREL CAPSULE COUPEURK832912GELENDER VACUUM FIXATION RING SYSK832996SURGICAL IOP MONITORK832911ABBOTT GLOBE HOLDERK831702RARE-EARTH INTRA-OCULAR MAGNET

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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