Embrace
FDA 510(k) K101373 · Izi Medical Products, Inc.
510(k) numberK101373
Submission
- Device name
- Embrace
- Applicant
- Izi Medical Products, Inc.
Baltimore, MD, US - Received
- May 17, 2010
- Decision date
- September 15, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K142344 | DISPOSABLE PASSIVE ACCESSORY FOR MEDTRONIC StealthStation SystemHAW · Traditional | 03/20/2015SE |
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Questions and answers
When was Embrace cleared by the FDA?
Embrace (K101373) received a 510(k) decision of Substantially Equivalent on September 15, 2010, 121 days after the submission was received.
What is the product code of K101373?
The FDA product code is IZH – System, X-Ray, Mammographic, a Class II (moderate risk) device regulated under 21 CFR 892.1710.