Vascumap Medical Air Plethysmograph
FDA 510(k) K914200 · Carolina Medical Electronics
510(k) numberK914200
Submission
- Device name
- Vascumap Medical Air Plethysmograph
- Applicant
- Carolina Medical Electronics
King, NC, US - Received
- September 19, 1991
- Decision date
- November 7, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DSB – Plethysmograph, Impedance
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2770
- Specialty
- Cardiovascular
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| K810561 | Dopscan Model 1050DPW · Traditional | 04/10/1981SE |
| K801647 | Sonacolor 6100DXY · Traditional | 08/20/1980SE |
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Questions and answers
When was Vascumap Medical Air Plethysmograph cleared by the FDA?
Vascumap Medical Air Plethysmograph (K914200) received a 510(k) decision of Substantially Equivalent on November 7, 1991, 49 days after the submission was received.
What is the product code of K914200?
The FDA product code is DSB – Plethysmograph, Impedance, a Class II (moderate risk) device regulated under 21 CFR 870.2770.