Xomed Ionesthetizer(Tm)

FDA 510(k) K884834 · Xomed, Inc.

Unknown

510(k) numberK884834

Submission

Device name
Xomed Ionesthetizer(Tm)
Applicant
Xomed, Inc.
Jacksonville, FL, US
Received
November 18, 1988
Decision date
February 15, 1989
Decision
Unknown (SESD)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
EGJ – Device, Iontophoresis, Other Uses
Device class
Class II (moderate risk)
Regulation
21 CFR 890.5525
Specialty
Physical Medicine

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Questions and answers

When was Xomed Ionesthetizer(Tm) cleared by the FDA?

Xomed Ionesthetizer(Tm) (K884834) received a 510(k) decision of Unknown on February 15, 1989, 89 days after the submission was received.

What is the product code of K884834?

The FDA product code is EGJ – Device, Iontophoresis, Other Uses, a Class II (moderate risk) device regulated under 21 CFR 890.5525.