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FDA 510(k)

ALTAIR-DISC RECORDER

K-Number: K942565 · 1994-12-05

ApplicantBurdick Corp.
Decision Date1994-12-05
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ALTAIR-DISC RECORDER is the device name listed in this FDA 510(k) record. The listed applicant is Burdick Corp.. It received FDA 510(k) clearance on 1994-12-05 under 510(k) number K942565. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALTAIR-DISC RECORDER?

ALTAIR-DISC RECORDER is a medical device that received FDA 510(k) clearance on 1994-12-05. The listed applicant is Burdick Corp.. The 510(k) number is K942565.

When did ALTAIR-DISC RECORDER receive FDA 510(k) clearance?

ALTAIR-DISC RECORDER received FDA 510(k) clearance on 1994-12-05, under 510(k) number K942565.

Who is the listed applicant for ALTAIR-DISC RECORDER?

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

What is the FDA product code for ALTAIR-DISC RECORDER?

The FDA product code for ALTAIR-DISC RECORDER is DQK.

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Other records listing Burdick 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.

K941351BURDICK PRO2 OXIMETERK903565E560 ELECTROCARDIOGRAPHK904032ELITE II ELECTROCARDIOGRAPHK900729NEOSERV 824K885085ERGOMED 840/ERGOMED 840LK892835E350 ELECTROCARDIOGRAPH

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Related Devices (Code: DQK)

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.

K261729EnSite™ X EP SystemAbbott MedicalK262005Affera Integrated Mapping SystemMedtronic, Inc.K253692AVVIGO™+ Multi-Modality Guidance SystemBoston ScientificK253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott MedicalK252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, 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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