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FDA 510(k)

BILI-METER

K-Number: K953005 · 1995-09-28

ApplicantOlympic Medical Corp.
Decision Date1995-09-28
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BILI-METER is the device name listed in this FDA 510(k) record. The listed applicant is Olympic Medical Corp.. It received FDA 510(k) clearance on 1995-09-28 under 510(k) number K953005. The device is classified under product code JJQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BILI-METER?

BILI-METER is a medical device that received FDA 510(k) clearance on 1995-09-28. The listed applicant is Olympic Medical Corp.. The 510(k) number is K953005.

When did BILI-METER receive FDA 510(k) clearance?

BILI-METER received FDA 510(k) clearance on 1995-09-28, under 510(k) number K953005.

Who is the listed applicant for BILI-METER?

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

What is the FDA product code for BILI-METER?

The FDA product code for BILI-METER is JJQ.

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Other records listing Olympic Medical Corp. 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.

K081094OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500K031149OLYMPIC CFM 6000K020335OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM, MODEL 5330K001056OLYMPIC WARM-UPK983229OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEMK971601OLYMPIC BILI-BASSINET

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Related Devices (Code: JJQ)

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.

K013371UBIT-IR300 INFRARED SPECTROMETRY SYSTEMOtsuka Pharmaceutical Co., Ltd.K980120DIGENE DML 2000 MICROPLATE LUMINOMETERDigene Corp.K973938ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READERSfri, Inc.K974762STAT TRACKSAwareness Technology, Inc.K962113ANTHOS PHACTS VERSION MICROPLATE READERColumbia Bioscience, Inc.K961183CBI 7520 READERColumbia Bioscience, Inc.

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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