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FDA 510(k)

BIOCHEM 3100 OXIMETER

K-Number: K893877 · 1989-12-20

ApplicantBiochem International, Inc.
Decision Date1989-12-20
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIOCHEM 3100 OXIMETER is the device name listed in this FDA 510(k) record. The listed applicant is Biochem International, Inc.. It received FDA 510(k) clearance on 1989-12-20 under 510(k) number K893877. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOCHEM 3100 OXIMETER?

BIOCHEM 3100 OXIMETER is a medical device that received FDA 510(k) clearance on 1989-12-20. The listed applicant is Biochem International, Inc.. The 510(k) number is K893877.

When did BIOCHEM 3100 OXIMETER receive FDA 510(k) clearance?

BIOCHEM 3100 OXIMETER received FDA 510(k) clearance on 1989-12-20, under 510(k) number K893877.

Who is the listed applicant for BIOCHEM 3100 OXIMETER?

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

What is the FDA product code for BIOCHEM 3100 OXIMETER?

The FDA product code for BIOCHEM 3100 OXIMETER is DQO.

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Other records listing Biochem International, Inc. as applicant

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Related Devices (Code: DQO)

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.

K261455Arterial Pressure Monitoring Set/TraySpectrum VascularK252702Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602NBioptimal International Pte. , Ltd.K254278Arterial Pressure Monitoring Set/TraySpectrum VascularK250751DualView CatheterTerumo CorporationK242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterGentuity, LLCK242420pNOVUS 21 MicrocatheterPhenox, Ltd.

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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