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FDA 510(k)

DIGITAL PULSE METER HRM-100E & ETC.

K-Number: K850449 · 1986-12-04

ApplicantSanyo Electric, Inc.
Decision Date1986-12-04
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DIGITAL PULSE METER HRM-100E & ETC. is the device name listed in this FDA 510(k) record. The listed applicant is Sanyo Electric, Inc.. It received FDA 510(k) clearance on 1986-12-04 under 510(k) number K850449. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGITAL PULSE METER HRM-100E & ETC.?

DIGITAL PULSE METER HRM-100E & ETC. is a medical device that received FDA 510(k) clearance on 1986-12-04. The listed applicant is Sanyo Electric, Inc.. The 510(k) number is K850449.

When did DIGITAL PULSE METER HRM-100E & ETC. receive FDA 510(k) clearance?

DIGITAL PULSE METER HRM-100E & ETC. received FDA 510(k) clearance on 1986-12-04, under 510(k) number K850449.

Who is the listed applicant for DIGITAL PULSE METER HRM-100E & ETC.?

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

What is the FDA product code for DIGITAL PULSE METER HRM-100E & ETC.?

The FDA product code for DIGITAL PULSE METER HRM-100E & ETC. is DRT.

Related Clinical Trials

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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Other records listing Sanyo Electric, 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.

K822692DIGITAL PULSE METER (73 BWS) #HRM-100EK822768ELECTROCARDIOGRAPH (74 DPS) #YM-102

Related Devices (Code: DRT)

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.

K254058DistaSense(TM) (v1)Life Detection TechnologiesK261286The Circadia C300 System (C300)Circadia Health, Inc.K252676The Circadia C300 System (C300)Circadia Health, Inc.K253388Sleepiz One+ (Model 2.5)Sleepiz AGK251364Sleepiz One+ (2.5)Sleepiz AGK234003The Circadia C200 SystemCircadia Technologies, Ltd.

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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