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FDA 510(k)

LEAD MODIFICATION

K-Number: K770135 · 1977-02-07

ApplicantElema-Schonander, Inc.
Decision Date1977-02-07
Product CodeDXY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LEAD MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Elema-Schonander, Inc.. It received FDA 510(k) clearance on 1977-02-07 under 510(k) number K770135. 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 LEAD MODIFICATION?

LEAD MODIFICATION is a medical device that received FDA 510(k) clearance on 1977-02-07. The listed applicant is Elema-Schonander, Inc.. The 510(k) number is K770135.

When did LEAD MODIFICATION receive FDA 510(k) clearance?

LEAD MODIFICATION received FDA 510(k) clearance on 1977-02-07, under 510(k) number K770135.

Who is the listed applicant for LEAD MODIFICATION?

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

What is the FDA product code for LEAD MODIFICATION?

The FDA product code for LEAD MODIFICATION is DXY. This falls under the Clinical Chemistry category.

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Other records listing Elema-Schonander, 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.

K934944MPQ-42K904103SEP 90K903576PUCK 90MK842903SEP PROGRAMMER FOR PUCK U & UD FILMCHANGK842911PUCK U & UD CUTFILM CHANGERSK840389SEP PROGRAMMER SEP-M/SINGLE-PLANE &

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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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