Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SYVA EDMS

K-Number: K912055 · 1991-06-10

ApplicantSyva Co.
Decision Date1991-06-10
Product CodeJJF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SYVA EDMS is the device name listed in this FDA 510(k) record. The listed applicant is Syva Co.. It received FDA 510(k) clearance on 1991-06-10 under 510(k) number K912055. The device is classified under product code JJF. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYVA EDMS?

SYVA EDMS is a medical device that received FDA 510(k) clearance on 1991-06-10. The listed applicant is Syva Co.. The 510(k) number is K912055.

When did SYVA EDMS receive FDA 510(k) clearance?

SYVA EDMS received FDA 510(k) clearance on 1991-06-10, under 510(k) number K912055.

Who is the listed applicant for SYVA EDMS?

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

What is the FDA product code for SYVA EDMS?

The FDA product code for SYVA EDMS is JJF.

Other records listing Syva Co. 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.

View all 448 devices →

Related Devices (Code: JJF)

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.

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.

↑