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FDA 510(k)

CPI MODEL 2215

K-Number: K923398 · 1992-08-14

ApplicantSeamed Corp.
Decision Date1992-08-14
Product CodeDTE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CPI MODEL 2215 is the device name listed in this FDA 510(k) record. The listed applicant is Seamed Corp.. It received FDA 510(k) clearance on 1992-08-14 under 510(k) number K923398. The device is classified under product code DTE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CPI MODEL 2215?

CPI MODEL 2215 is a medical device that received FDA 510(k) clearance on 1992-08-14. The listed applicant is Seamed Corp.. The 510(k) number is K923398.

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

CPI MODEL 2215 received FDA 510(k) clearance on 1992-08-14, under 510(k) number K923398.

Who is the listed applicant for CPI MODEL 2215?

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?

The FDA product code for CPI MODEL 2215 is DTE.

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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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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.

K915364CHRONOCOR VI MODEL 5012K912507CPI MODEL 2215 & SEAMED MODEL 3400K910223CPI MODEL 2215/SEAMED MODEL 3400K883930SEAMED MODEL 3300 DUAL CHAMBER PACING SYSTEM ANALYK872551SEAMED MODEL 3200K863903SEA MED MODEL 6000

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Related Devices (Code: DTE)

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.

K241781Solo Pace ControlSolo Pace, Inc.K232721Lifetech Cardio Temporary PacemakerShenzhen Lifetech Cardio Medical Electronics Co., Ltd.K201011Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc.K190825Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc.K182839Lifetech Cardio Model 8301 Temporary PacemakerShenzhen Lifetech Cardio Medical Electronics Co., Ltd.K181973Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, 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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