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FDA 510(k)

AUTOMATIC SINGLE CHANNEL ECG #399

K-Number: K821888 · 1982-07-30

ApplicantBirtcher Corp.
Decision Date1982-07-30
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AUTOMATIC SINGLE CHANNEL ECG #399 is the device name listed in this FDA 510(k) record. The listed applicant is Birtcher Corp.. It received FDA 510(k) clearance on 1982-07-30 under 510(k) number K821888. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOMATIC SINGLE CHANNEL ECG #399?

AUTOMATIC SINGLE CHANNEL ECG #399 is a medical device that received FDA 510(k) clearance on 1982-07-30. The listed applicant is Birtcher Corp.. The 510(k) number is K821888.

When did AUTOMATIC SINGLE CHANNEL ECG #399 receive FDA 510(k) clearance?

AUTOMATIC SINGLE CHANNEL ECG #399 received FDA 510(k) clearance on 1982-07-30, under 510(k) number K821888.

Who is the listed applicant for AUTOMATIC SINGLE CHANNEL ECG #399?

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

What is the FDA product code for AUTOMATIC SINGLE CHANNEL ECG #399?

The FDA product code for AUTOMATIC SINGLE CHANNEL ECG #399 is DPS.

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Other records listing Birtcher 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.

K881328MODEL 375 ECGK860687BIRT-A-SWITCH, DSP PUSH BUTTON, MODEL NO. 768K860718ELECTROSURGERY PENCIL, MODEL 767K854814SURGICAL CAUTERIES MODELS 775-11,12,13,31,32 & 33K854864BI-POLAR FORCEPSK850943MODEL 775 BIPOLAR COAGULATOR

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Related Devices (Code: DPS)

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.

K254255S-Patch CardioAIWellysis Corp.K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)WithingsK250569Cardiologs Holter PlatformPhilips France Commercial

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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