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FDA 510(k)

MODEL 375 ECG

K-Number: K881328 · 1988-05-18

ApplicantBirtcher Corp.
Decision Date1988-05-18
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL 375 ECG is the device name listed in this FDA 510(k) record. The listed applicant is Birtcher Corp.. It received FDA 510(k) clearance on 1988-05-18 under 510(k) number K881328. 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 MODEL 375 ECG?

MODEL 375 ECG is a medical device that received FDA 510(k) clearance on 1988-05-18. The listed applicant is Birtcher Corp.. The 510(k) number is K881328.

When did MODEL 375 ECG receive FDA 510(k) clearance?

MODEL 375 ECG received FDA 510(k) clearance on 1988-05-18, under 510(k) number K881328.

Who is the listed applicant for MODEL 375 ECG?

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 MODEL 375 ECG?

The FDA product code for MODEL 375 ECG 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.

K860718ELECTROSURGERY PENCIL, MODEL 767K860687BIRT-A-SWITCH, DSP PUSH BUTTON, MODEL NO. 768K854814SURGICAL CAUTERIES MODELS 775-11,12,13,31,32 & 33K854864BI-POLAR FORCEPSK850943MODEL 775 BIPOLAR COAGULATORK850668ELECTROSURGICAL UNIT 774

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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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