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FDA 510(k)

OVALITH 10BP

K-Number: K781377 · 1978-12-04

ApplicantCoratomic, Inc.
Decision Date1978-12-04
Product CodeDXY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OVALITH 10BP is the device name listed in this FDA 510(k) record. The listed applicant is Coratomic, Inc.. It received FDA 510(k) clearance on 1978-12-04 under 510(k) number K781377. 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 OVALITH 10BP?

OVALITH 10BP is a medical device that received FDA 510(k) clearance on 1978-12-04. The listed applicant is Coratomic, Inc.. The 510(k) number is K781377.

When did OVALITH 10BP receive FDA 510(k) clearance?

OVALITH 10BP received FDA 510(k) clearance on 1978-12-04, under 510(k) number K781377.

Who is the listed applicant for OVALITH 10BP?

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

What is the FDA product code for OVALITH 10BP?

The FDA product code for OVALITH 10BP is DXY. This falls under the Clinical Chemistry category.

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Other records listing Coratomic, 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.

K863365MODIFICATION OF STERILITY CYCLE PARAMETERSK822791CORATOMIC #VX5-105 & VX5-205 PULSE GEN.K820939C-101-PK821033CORATOMIC MODEL OVALITH-920K821014CORATOMIC MODEL OVALITH 920BPK810808CORATOMIC MODEL OVALITH-920

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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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