510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K060077Substantially Equivalent

Rtt Digital Wrist Blood Pressure Monitor, Model Rtw-8010A

Real Tone Technology Corp., Shanghai, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K060077 is the FDA 510(k) clearance record for RTT DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL RTW-8010A, a class II device, cleared for Real Tone Technology Corp. on under FDA product code DXN (System, Measurement, Blood-Pressure, Non-Invasive). FDA records list one 510(k) clearance for Real Tone Technology Corp. As of , FDA records show no recalls naming K060077.

Clearance record

Decision date
Received
(57 days to decision)
Product code
DXN System, Measurement, Blood-Pressure, Non-Invasive
Regulation
21 CFR 870.1130
Device class
Class II
Review panel
Cardiovascular
Applicant
Real Tone Technology Corp. Xi Huang Rd.; Xinzhuang Town, Shanghai, CN
510(k) summary
Statement
Third party review
No

Clearances, product code DXN

Trailing 12 months
30 clearances under product code DXN in the twelve months to October 2026, April 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code DXN, trailing twelve months
MonthClearances
November 20250
December 20251
January 20262
February 20264
March 20262
April 20265
May 20263
June 20264
July 20262
August 20264
September 20262
October 20261