510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K973318Substantially Equivalent

Mobimed System, (Pegasus and Polaris)

Ortivus Us, Inc., Minneapolis, MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K973318 is the FDA 510(k) clearance record for MOBIMED SYSTEM, (PEGASUS AND POLARIS), a class II device, cleared for Ortivus Us, Inc. on under FDA product code MSX (System, Network And Communication, Physiological Monitors). FDA records list one 510(k) clearance for Ortivus Us, Inc. As of , FDA records show no recalls naming K973318.

Clearance record

Decision date
Received
(168 days to decision)
Product code
MSX System, Network And Communication, Physiological Monitors
Regulation
21 CFR 870.2300
Device class
Class II
Review panel
Cardiovascular
Applicant
Ortivus Us, Inc. 6740 Riverview Ter., Minneapolis, MN
510(k) summary
Summary
Third party review
No

Clearances, product code MSX

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