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FDA 510(k)

TERUMO OVATION SPECTROPHOTOMETER

K-Number: K864285 · 1987-01-09

ApplicantTerumo Medical Corp.
Decision Date1987-01-09
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TERUMO OVATION SPECTROPHOTOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Medical Corp.. It received FDA 510(k) clearance on 1987-01-09 under 510(k) number K864285. 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 TERUMO OVATION SPECTROPHOTOMETER?

TERUMO OVATION SPECTROPHOTOMETER is a medical device that received FDA 510(k) clearance on 1987-01-09. The listed applicant is Terumo Medical Corp.. The 510(k) number is K864285.

When did TERUMO OVATION SPECTROPHOTOMETER receive FDA 510(k) clearance?

TERUMO OVATION SPECTROPHOTOMETER received FDA 510(k) clearance on 1987-01-09, under 510(k) number K864285.

Who is the listed applicant for TERUMO OVATION SPECTROPHOTOMETER?

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

What is the FDA product code for TERUMO OVATION SPECTROPHOTOMETER?

The FDA product code for TERUMO OVATION SPECTROPHOTOMETER is JJQ.

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Other records listing Terumo 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.

K111606PINNACLE PRECISION ACCESS SYSTEMK111556GLIDECROSS SUPPORT CATHETERK110540TERUMO SUPPORT CATHETERK102008GLIDESHEATHK091329PINNACLE DESTINATION PERIPHERAL GUIDING SHEATHK082997TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER

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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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