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FDA 510(k)

STILITH CARDIAC PACEMAKERS-M. 60 & 120

K-Number: K780781 · 1978-07-27

ApplicantR.E. Brown Co., Inc.
Decision Date1978-07-27
Product CodeDXY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

STILITH CARDIAC PACEMAKERS-M. 60 & 120 is the device name listed in this FDA 510(k) record. The listed applicant is R.E. Brown Co., Inc.. It received FDA 510(k) clearance on 1978-07-27 under 510(k) number K780781. 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 STILITH CARDIAC PACEMAKERS-M. 60 & 120?

STILITH CARDIAC PACEMAKERS-M. 60 & 120 is a medical device that received FDA 510(k) clearance on 1978-07-27. The listed applicant is R.E. Brown Co., Inc.. The 510(k) number is K780781.

When did STILITH CARDIAC PACEMAKERS-M. 60 & 120 receive FDA 510(k) clearance?

STILITH CARDIAC PACEMAKERS-M. 60 & 120 received FDA 510(k) clearance on 1978-07-27, under 510(k) number K780781.

Who is the listed applicant for STILITH CARDIAC PACEMAKERS-M. 60 & 120?

The FDA 510(k) record lists R.E. Brown Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STILITH CARDIAC PACEMAKERS-M. 60 & 120?

The FDA product code for STILITH CARDIAC PACEMAKERS-M. 60 & 120 is DXY. This falls under the Clinical Chemistry category.

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Other records listing R.E. Brown Co., 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.

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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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