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FDA 510(k)

MODIFICATION TO:APEX MEDICAL IF-4100

K-Number: K013813 · 2001-12-14

ApplicantApex Medical Corp.
Decision Date2001-12-14
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO:APEX MEDICAL IF-4100 is the device name listed in this FDA 510(k) record. The listed applicant is Apex Medical Corp.. It received FDA 510(k) clearance on 2001-12-14 under 510(k) number K013813. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO:APEX MEDICAL IF-4100?

MODIFICATION TO:APEX MEDICAL IF-4100 is a medical device that received FDA 510(k) clearance on 2001-12-14. The listed applicant is Apex Medical Corp.. The 510(k) number is K013813.

When did MODIFICATION TO:APEX MEDICAL IF-4100 receive FDA 510(k) clearance?

MODIFICATION TO:APEX MEDICAL IF-4100 received FDA 510(k) clearance on 2001-12-14, under 510(k) number K013813.

Who is the listed applicant for MODIFICATION TO:APEX MEDICAL IF-4100?

The FDA 510(k) record lists Apex Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO:APEX MEDICAL IF-4100?

The FDA product code for MODIFICATION TO:APEX MEDICAL IF-4100 is GXY.

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Other records listing Apex Medical Corp. as applicant

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K213577VenAir, Sequential Compression SystemK193206WiZARD 510 Nasal MaskK182394WiZARD 310/320 Series CPAP MaskK121642WIZARD 230 NASAL PILOW MASKK112079APEX MEDICAL XT AUTO CPAP WITH COMPLIANCE IMPROVEMENT ALGORITHM 9S-005720K120035APEX MEDICAL ICH CPAP SERIES (9S-007XXX)

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Related Devices (Code: GXY)

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.

K262654Dexus Prosthetic System (MSL2, MSR2)Zhejiang Qiangnao Technology Co.,LtdK260578Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US)Ambu A/SK261442Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode ArrayCadwell Industries, Inc.K261522BioWave BioWrapsBiowave CorporationK253237Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)Elde Medikal Sanayi ve Ticaret Anonim SirketiK254183MR Conditional Cup ElectrodesTechnomed Europe

Official Source

View on FDA Database →

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

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