Linde Oxygen Concentrator Model Loc-Hca

FDA 510(k) K781454 · Union Carbide Corp.

Substantially Equivalent

510(k) numberK781454

Submission

Device name
Linde Oxygen Concentrator Model Loc-Hca
Applicant
Union Carbide Corp.
Mchenry, IL, US
Received
August 22, 1978
Decision date
September 20, 1978
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
CHW – Titrimetric With Edta And Indicator, Calcium
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1145
Specialty
Clinical Chemistry

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K113521Calcium Gen. 2CHW · Traditional Roche Diagnostics05/08/2012SE

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Questions and answers

When was Linde Oxygen Concentrator Model Loc-Hca cleared by the FDA?

Linde Oxygen Concentrator Model Loc-Hca (K781454) received a 510(k) decision of Substantially Equivalent on September 20, 1978, 29 days after the submission was received.

What is the product code of K781454?

The FDA product code is CHW – Titrimetric With Edta And Indicator, Calcium, a Class II (moderate risk) device regulated under 21 CFR 862.1145.