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FDA 510(k)

LABEL CHG FOR ERIKA MODEL 9608 ARTERIAL BLOOD LINE

K-Number: K870722 · 1988-09-14

ApplicantNational Medical Care, Medical Products Div., Inc.
Decision Date1988-09-14
Product CodeFJK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LABEL CHG FOR ERIKA MODEL 9608 ARTERIAL BLOOD LINE is the device name listed in this FDA 510(k) record. The listed applicant is National Medical Care, Medical Products Div., Inc.. It received FDA 510(k) clearance on 1988-09-14 under 510(k) number K870722. The device is classified under product code FJK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LABEL CHG FOR ERIKA MODEL 9608 ARTERIAL BLOOD LINE?

LABEL CHG FOR ERIKA MODEL 9608 ARTERIAL BLOOD LINE is a medical device that received FDA 510(k) clearance on 1988-09-14. The listed applicant is National Medical Care, Medical Products Div., Inc.. The 510(k) number is K870722.

When did LABEL CHG FOR ERIKA MODEL 9608 ARTERIAL BLOOD LINE receive FDA 510(k) clearance?

LABEL CHG FOR ERIKA MODEL 9608 ARTERIAL BLOOD LINE received FDA 510(k) clearance on 1988-09-14, under 510(k) number K870722.

Who is the listed applicant for LABEL CHG FOR ERIKA MODEL 9608 ARTERIAL BLOOD LINE?

The FDA 510(k) record lists National Medical Care, Medical Products Div., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LABEL CHG FOR ERIKA MODEL 9608 ARTERIAL BLOOD LINE?

The FDA product code for LABEL CHG FOR ERIKA MODEL 9608 ARTERIAL BLOOD LINE is FJK.

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Other records listing National Medical Care, Medical Products Div., 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.

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Related Devices (Code: FJK)

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.

K252423NovaLine Tubing Set for Hemodialysis (BL 124)Bain Medical Equipment (Guangzhou) Co., Ltd.K251341VITAL Tubing Sets for HemodialysisVital Healthcare Sdn. Bhd.K251442TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)Ningbo Tianyi Medical Appliance Co., Ltd.K243607Moda-flx Hemodialysis System™ Cartridge (102121-001 )Diality, Inc.K213992CombiSet Hemodialysis Blood Tubing SetFresenius Medical Care Renal Therapies Group, LLCK210782Tablo CartridgeOutset Medical, 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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