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FDA 510(k)

SEAMED MODEL 3000

K-Number: K860462 · 1986-08-19

ApplicantSeamed Corp.
Decision Date1986-08-19
Product CodeDTC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SEAMED MODEL 3000 is the device name listed in this FDA 510(k) record. The listed applicant is Seamed Corp.. It received FDA 510(k) clearance on 1986-08-19 under 510(k) number K860462. The device is classified under product code DTC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEAMED MODEL 3000?

SEAMED MODEL 3000 is a medical device that received FDA 510(k) clearance on 1986-08-19. The listed applicant is Seamed Corp.. The 510(k) number is K860462.

When did SEAMED MODEL 3000 receive FDA 510(k) clearance?

SEAMED MODEL 3000 received FDA 510(k) clearance on 1986-08-19, under 510(k) number K860462.

Who is the listed applicant for SEAMED MODEL 3000?

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

What is the FDA product code for SEAMED MODEL 3000?

The FDA product code for SEAMED MODEL 3000 is DTC.

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Other records listing Seamed Corp. 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.

K923398CPI MODEL 2215K915364CHRONOCOR VI MODEL 5012K912507CPI MODEL 2215 & SEAMED MODEL 3400K910223CPI MODEL 2215/SEAMED MODEL 3400K883930SEAMED MODEL 3300 DUAL CHAMBER PACING SYSTEM ANALYK872551SEAMED MODEL 3200

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Related Devices (Code: DTC)

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.

K170815PSA CableBoston Scientific CorporationK083674PK-141 PATIENT CABLEBiotronik, Inc.K011729SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000Dni Nevada, Inc.K002497MODEL 4810 ANALYZER OUTPUT ADAPTERPace MedicalK961582EXTERNAL PACEMAKER ANALYZER, MODEL PMT 100North American Technical Services Corp.K903966EXTERNAL PACEMAKER ANALYZER MODEL PMA-1Bio-Tek Instruments, Inc.

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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