510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K914200Substantially Equivalent

Vascumap Medical Air Plethysmograph

Carolina Medical Electronics, King NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K914200 is the FDA 510(k) clearance record for VASCUMAP MEDICAL AIR PLETHYSMOGRAPH, a class II device, cleared for Carolina Medical Electronics on under FDA product code DSB (Plethysmograph, Impedance). FDA records list 11 510(k) clearances for Carolina Medical Electronics, from to . As of , FDA records show no recalls naming K914200.

Clearance record

Decision date
Received
(49 days to decision)
Product code
DSB Plethysmograph, Impedance
Regulation
21 CFR 870.2770
Device class
Class II
Review panel
Cardiovascular
Applicant
Carolina Medical Electronics P. O. Box 307, King NC
510(k) summary
Statement
Third party review
No

Clearances, product code DSB

Trailing 12 months
2 clearances under product code DSB in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DSB, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260