Cardiac Wall Motion Device
FDA 510(k) K833728 · Intl. Medical, Inc.
510(k) numberK833728
Submission
- Device name
- Cardiac Wall Motion Device
- Applicant
- Intl. Medical, Inc.
Mchenry, IL, US - Received
- October 25, 1983
- Decision date
- February 10, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DSB – Plethysmograph, Impedance
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2770
- Specialty
- Cardiovascular
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| K923200 | Amcath Disposable Cytology BrushFDX · Traditional | 12/07/1992SE |
| K915142 | Amcath Disposable Biopsy ForcepsFCF · Traditional | 01/10/1992SE |
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Questions and answers
When was Cardiac Wall Motion Device cleared by the FDA?
Cardiac Wall Motion Device (K833728) received a 510(k) decision of Substantially Equivalent on February 10, 1984, 108 days after the submission was received.
What is the product code of K833728?
The FDA product code is DSB – Plethysmograph, Impedance, a Class II (moderate risk) device regulated under 21 CFR 870.2770.