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FDA 510(k)

B SMART MODEL 1

K-Number: K961817 · 1997-07-23

ApplicantKoven Technology, Inc.
Decision Date1997-07-23
Product CodeLEL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

B SMART MODEL 1 is the device name listed in this FDA 510(k) record. The listed applicant is Koven Technology, Inc.. It received FDA 510(k) clearance on 1997-07-23 under 510(k) number K961817. The device is classified under product code LEL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the B SMART MODEL 1?

B SMART MODEL 1 is a medical device that received FDA 510(k) clearance on 1997-07-23. The listed applicant is Koven Technology, Inc.. The 510(k) number is K961817.

When did B SMART MODEL 1 receive FDA 510(k) clearance?

B SMART MODEL 1 received FDA 510(k) clearance on 1997-07-23, under 510(k) number K961817.

Who is the listed applicant for B SMART MODEL 1?

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

What is the FDA product code for B SMART MODEL 1?

The FDA product code for B SMART MODEL 1 is LEL.

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Other records listing Koven Technology, Inc. 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.

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Related Devices (Code: LEL)

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.

K252981EmbraceMiniEmpatica S.r.l.K251574Sleep WatchAmbulatory Monitoring, Inc.K243513DCM (PW-DCM)Pneumowave, Ltd.K233987VERABAND™Arbor Medical Innovations, LLCK233618Oxevision Sleep DeviceOxehealth LimitedK231532ActiGraph LEAP activity monitor (ActiGraph LEAP)Actigraph, LLC

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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