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FDA 510(k)

KALOS-03

K-Number: K812218 · 1981-10-13

ApplicantBiotronik Sales, Inc.
Decision Date1981-10-13
Product CodeDXY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

KALOS-03 is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik Sales, Inc.. It received FDA 510(k) clearance on 1981-10-13 under 510(k) number K812218. The device is classified under product code DXY. It was reviewed by the CV advisory panel. Product code DXY falls under the category of Clinical Chemistry, which covers reagents and instruments for chemical analysis of clinical samples. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KALOS-03?

KALOS-03 is a medical device that received FDA 510(k) clearance on 1981-10-13. The listed applicant is Biotronik Sales, Inc.. The 510(k) number is K812218.

When did KALOS-03 receive FDA 510(k) clearance?

KALOS-03 received FDA 510(k) clearance on 1981-10-13, under 510(k) number K812218.

Who is the listed applicant for KALOS-03?

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

What is the FDA product code for KALOS-03?

The FDA product code for KALOS-03 is DXY. This falls under the Clinical Chemistry category.

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Other records listing Biotronik Sales, 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.

K875199NP BIPOLAR ENDOCARDIAL LEAD W/VS-1 CONNECTORK853194ERA-20K860036EDP-20 PACEMAKERK863878TRIOS-M VS-1 PULSE GENERATORK863879NEOS-M VS-1 PULSE GENERATORK863480BIOTRONIK PERMANENT PACEMAKER ELECTRODE

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Related Devices (Code: DXY)

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.

K993434PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-ABiotronik, Inc.K970072OPUS S MODEL 4121 AND 4124 PACEMAKERSEla Medical, Inc.K945627PIKOS LP 01, PIKOS LP E01Biotronik, Inc.K953866MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION)Medtronic VascularK954092ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION)Medtronic VascularK953417MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORSCook Pacemaker Corp.

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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