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FDA 510(k)

RHYTHMSTAT XL

K-Number: K971650 · 1997-12-04

ApplicantData Critical Corp.
Decision Date1997-12-04
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RHYTHMSTAT XL is the device name listed in this FDA 510(k) record. The listed applicant is Data Critical Corp.. It received FDA 510(k) clearance on 1997-12-04 under 510(k) number K971650. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RHYTHMSTAT XL?

RHYTHMSTAT XL is a medical device that received FDA 510(k) clearance on 1997-12-04. The listed applicant is Data Critical Corp.. The 510(k) number is K971650.

When did RHYTHMSTAT XL receive FDA 510(k) clearance?

RHYTHMSTAT XL received FDA 510(k) clearance on 1997-12-04, under 510(k) number K971650.

Who is the listed applicant for RHYTHMSTAT XL?

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

What is the FDA product code for RHYTHMSTAT XL?

The FDA product code for RHYTHMSTAT XL is DXH. This falls under the Hematology category.

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Other records listing Data Critical 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.

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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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