FDA Registration Active 🇺🇸 United States

9011 (13L4w)

Reg #: 2532090 · FEI: 3003408255 · Expires 2025
Products
3
Proprietary Names
59
Establishment Types
1
Classifications
3

Registration Details

Registration Name
SOUND TECHNOLOGY INC.
Registration Number
2532090
FEI Number
3003408255
Status
Active
Expiry Year
2025
Initial Importer
No
Address
401 Science Park Road
City
STATE COLLEGE
State
PA
ZIP
16803
Country
US

Regulatory Submissions

510(k) Number
K180737

Owner / Operator

Firm Name
GE HealthCare Technologies Inc.
Operator Number
9912004
Address
3000 N. Grandview Blvd
City
Waukesha
State
WI
Postal Code
53188
Country
US

Products

Device Name Product Code
Transducer, Ultrasonic, Diagnostic ITX
System, Imaging, Pulsed Doppler, Ultrasonic IYN
System, Imaging, Pulsed Echo, Ultrasonic IYO

Proprietary Names

9011 (13L4w) 9018 (E14C4t) 9029 (E13C2) 9076 (I13C3f) 9062 (N13C5) 9024 (I12C5b) 9016 (I14C5T) 9038 (X14L4) UA1251 9007 (N20P6) UA1326 UA0671 (Water Standoff) 9066 (I12C4f) UA1329-S (Sterile) 9027 (T7P2m) 9032 (8L2) UA1323-S (Sterile) 2300 (bk3000, bk3500, bk5000, bkActiv) UA1328 UA1338 (Sterile) 9048 (E14CL4b) UA1322-S (Sterile) UA1232 UA1349 UA1282 9026 (X12C4) 9015 (I14C5I) UA1324 UA0672 (Rectosigmoidoscope) UA1325w (Channel Bracket) UA1344 (Sterile) 9063 (N11C5s) 9052 (20R3) 9040 (6C2) UA1337 (Sterile) UA0673 (Rectosigmoidoscope) UA1346 (Sterile) UA2379 Integrated TR Fusion Kit 2300 9085 (5C1e) UA1336 (Sterile) 9002 (9C2) 9096 (Rob12C4) 9009 (X18L5s) 9019 (E10C4) UA1345 (Sterile) 9023 (6C2s) UA1239 UA1327 9051 (14L3) UA2390 Integrated TP Fusion Kit 2300 UA1325 (Channel Bracket) UA1250 UA1339 (Sterile) 7000 (bkViewer) UA1322-S14 (Sterile) 9034 (I12C5) 9070 (18L5) 9081 (18L5s) 9077 (5P1)

Establishment Types

Manufacture Medical Device