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FDA 510(k)

PULSE GENERATOR 678 B

K-Number: K820657 · 1982-04-15

ApplicantSiemens Elema AB
Decision Date1982-04-15
Product CodeDXY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PULSE GENERATOR 678 B is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Elema AB. It received FDA 510(k) clearance on 1982-04-15 under 510(k) number K820657. 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 PULSE GENERATOR 678 B?

PULSE GENERATOR 678 B is a medical device that received FDA 510(k) clearance on 1982-04-15. The listed applicant is Siemens Elema AB. The 510(k) number is K820657.

When did PULSE GENERATOR 678 B receive FDA 510(k) clearance?

PULSE GENERATOR 678 B received FDA 510(k) clearance on 1982-04-15, under 510(k) number K820657.

Who is the listed applicant for PULSE GENERATOR 678 B?

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

What is the FDA product code for PULSE GENERATOR 678 B?

The FDA product code for PULSE GENERATOR 678 B is DXY. This falls under the Clinical Chemistry category.

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Other records listing Siemens Elema AB 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.

K023354COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81EK010923KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392EK010925SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407EK002137CATHCOR DESKTOPK001315MODIFICATION TO KION ANESTHESIA SYSTEMK970839SERVO VENTILATOR 300A

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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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