Oxyconalpha with Option ECG

FDA 510(k) K984465 · Erich Jaeger B.V.

Substantially Equivalent

510(k) numberK984465

Submission

Device name: Oxyconalpha with Option ECG
Applicant: Erich Jaeger B.V.
Nl-3981 La Bunnik, NL
Received: December 16, 1998
Decision date: October 27, 1999
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

No product code recorded.

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More from Nihon Kohden America, Inc.

510(k)	Device	Decision
K992214	Oxycon ProBZC · Traditional	02/22/2000SE
K980094	Modification to the OxyconalphaBTY · Traditional	07/28/1998SE

Questions and answers

When was Oxyconalpha with Option ECG cleared by the FDA?

Oxyconalpha with Option ECG (K984465) received a 510(k) decision of Substantially Equivalent on October 27, 1999, 315 days after the submission was received.