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FDA 510(k)

Tablo Cartridge

K-Number: K210782 · 2021-11-26

ApplicantOutset Medical, Inc.
Decision Date2021-11-26
Product CodeFJK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Tablo Cartridge is the device name listed in this FDA 510(k) record. The listed applicant is Outset Medical, Inc.. It received FDA 510(k) clearance on 2021-11-26 under 510(k) number K210782. 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 Tablo Cartridge?

Tablo Cartridge is a medical device that received FDA 510(k) clearance on 2021-11-26. The listed applicant is Outset Medical, Inc.. The 510(k) number is K210782.

When did Tablo Cartridge receive FDA 510(k) clearance?

Tablo Cartridge received FDA 510(k) clearance on 2021-11-26, under 510(k) number K210782.

Who is the listed applicant for Tablo Cartridge?

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

What is the FDA product code for Tablo Cartridge?

The FDA product code for Tablo Cartridge is FJK.

Other records listing Outset Medical, 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, LLCK202796SANSIN Tubing Sets for HemodialysisJiangxi Sanxin Medtec Co., Ltd.

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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