510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K091696Substantially Equivalent

Savi Wireless, Model Pm500

Medicomp, Inc., Great Neck NY / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K091696 is the FDA 510(k) clearance record for SAVI WIRELESS, MODEL PM500, a class II device, cleared for Medicomp, Inc. on under FDA product code DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency). FDA records list 23 510(k) clearances for Medicomp, Inc., from to . As of , FDA records show no recalls naming K091696.

Clearance record

Decision date
Received
(138 days to decision)
Product code
DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Regulation
21 CFR 870.2910
Device class
Class II
Review panel
Cardiovascular
Applicant
Medicomp, Inc. 55 Northern Blvd., Suite 200, Great Neck NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DRG

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