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FDA 510(k)

CORE MONITORING SYSTEM-SP1475/6275/5607/5708/4575

K-Number: K921727 · 1994-05-10

ApplicantViggo-Spectramed
Decision Date1994-05-10
Product CodeKNF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CORE MONITORING SYSTEM-SP1475/6275/5607/5708/4575 is the device name listed in this FDA 510(k) record. The listed applicant is Viggo-Spectramed. It received FDA 510(k) clearance on 1994-05-10 under 510(k) number K921727. The device is classified under product code KNF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORE MONITORING SYSTEM-SP1475/6275/5607/5708/4575?

CORE MONITORING SYSTEM-SP1475/6275/5607/5708/4575 is a medical device that received FDA 510(k) clearance on 1994-05-10. The listed applicant is Viggo-Spectramed. The 510(k) number is K921727.

When did CORE MONITORING SYSTEM-SP1475/6275/5607/5708/4575 receive FDA 510(k) clearance?

CORE MONITORING SYSTEM-SP1475/6275/5607/5708/4575 received FDA 510(k) clearance on 1994-05-10, under 510(k) number K921727.

Who is the listed applicant for CORE MONITORING SYSTEM-SP1475/6275/5607/5708/4575?

The FDA 510(k) record lists Viggo-Spectramed as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CORE MONITORING SYSTEM-SP1475/6275/5607/5708/4575?

The FDA product code for CORE MONITORING SYSTEM-SP1475/6275/5607/5708/4575 is KNF.

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Related Devices (Code: KNF)

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.

K254303KARL STORZ SUPRALOOPKarl Storz SE & CO. KGK250705Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.K240503Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.K233848Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)Gynesonics, Inc.K222304Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.K211535Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, 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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