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FDA 510(k)

CPI MODEL 2215/SEAMED MODEL 3400

K-Number: K910223 · 1991-03-19

ApplicantSeamed Corp.
Decision Date1991-03-19
Product CodeDTC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CPI MODEL 2215/SEAMED MODEL 3400 is the device name listed in this FDA 510(k) record. The listed applicant is Seamed Corp.. It received FDA 510(k) clearance on 1991-03-19 under 510(k) number K910223. 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 CPI MODEL 2215/SEAMED MODEL 3400?

CPI MODEL 2215/SEAMED MODEL 3400 is a medical device that received FDA 510(k) clearance on 1991-03-19. The listed applicant is Seamed Corp.. The 510(k) number is K910223.

When did CPI MODEL 2215/SEAMED MODEL 3400 receive FDA 510(k) clearance?

CPI MODEL 2215/SEAMED MODEL 3400 received FDA 510(k) clearance on 1991-03-19, under 510(k) number K910223.

Who is the listed applicant for CPI MODEL 2215/SEAMED MODEL 3400?

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 CPI MODEL 2215/SEAMED MODEL 3400?

The FDA product code for CPI MODEL 2215/SEAMED MODEL 3400 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 3400K883930SEAMED MODEL 3300 DUAL CHAMBER PACING SYSTEM ANALYK872551SEAMED MODEL 3200K863903SEA MED MODEL 6000

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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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