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FDA 510(k)

MODIFICATION TO: BODYGUARD INFUSION SYSTEM

K-Number: K070718 · 2007-04-13

ApplicantCaesarea Medical Electronics , Ltd.
Decision Date2007-04-13
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: BODYGUARD INFUSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Caesarea Medical Electronics , Ltd.. It received FDA 510(k) clearance on 2007-04-13 under 510(k) number K070718. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO: BODYGUARD INFUSION SYSTEM?

MODIFICATION TO: BODYGUARD INFUSION SYSTEM is a medical device that received FDA 510(k) clearance on 2007-04-13. The listed applicant is Caesarea Medical Electronics , Ltd.. The 510(k) number is K070718.

When did MODIFICATION TO: BODYGUARD INFUSION SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO: BODYGUARD INFUSION SYSTEM received FDA 510(k) clearance on 2007-04-13, under 510(k) number K070718.

Who is the listed applicant for MODIFICATION TO: BODYGUARD INFUSION SYSTEM?

The FDA 510(k) record lists Caesarea Medical Electronics , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO: BODYGUARD INFUSION SYSTEM?

The FDA product code for MODIFICATION TO: BODYGUARD INFUSION SYSTEM is FRN.

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Other records listing Caesarea Medical Electronics , Ltd. 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.

K080954T34L SYRINGE DRIVERK070235BODYGUARD PAIN MANAGER INFUSION SYSTEMK061325BODYGAURD PAIN MANAGER INFUSION SYSTEMK060479MODIFICATION TO BODYGUARD INFUSION PUMP SYSTEMK050800NIKI T34 AND BODYGUARD T34 SYRINGE DRIVERSK042696BODYGUARD INFUSION PUMP SYSTEM

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Related Devices (Code: FRN)

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K253703RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionDeka R&D CorpK252015FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubingKoru Medical Systems, Inc.K251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)Baxter Healthcare CorporationK251640SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare CorporationK242752MRidium 3870 MRI Infusion Pump System (3870)Iradimed CorporationK243855BD Alaris Infusion System with Guardrails Suite MXCarefusion 303, 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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