Data / Medical devices / Japan / Hadeco, Inc.
Hadeco, Inc.: FDA-registered device maker in KAWASAKI Kanagawa, Japan, 12 510(k) clearances
Hadeco, Inc. is registered with the FDA (registration 9611033) in KAWASAKI Kanagawa, Japan. It lists 6 device types. The FDA files 12 510(k) clearances under its listings, the newest dated January 5, 2021. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9611033
- FEI number
- 3002807138
- Address
- 2-7-11 Arima Miyamae-Ku, KAWASAKI Kanagawa, Japan, 216-0003
- Owner or operator
- Hadeco, Inc. (8030313)
- Roles
- Manufacturer
- First device listed
- November 28, 2005
- Registered through
- 2027
- Brand names listed
- ACP-08, AD8HD307, BDP08MS8, BDP10MS8, BDP20MS8, BF8M15S8A, BT10M5S8A, BT10M5S8C and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Flowmeter, Blood, Cardiovascular | DPW | 2 | Manufacturer | accessdata.fda.gov |
| Monitor, Ultrasonic, Nonfetal | JAF | 2 | Manufacturer | accessdata.fda.gov |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | 2 | Manufacturer | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Manufacturer | accessdata.fda.gov |
| Transducer, Ultrasonic | JOP | 2 | Manufacturer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 5, 2021 | K201114 | Bidop 7 | DPW | Substantially Equivalent | Koven Technology, Inc. | accessdata.fda.gov |
| May 25, 2016 | K153762 | Smartdop XT6 | JOP | Substantially Equivalent | Koven Technology, Inc. | accessdata.fda.gov |
| January 17, 2014 | K131623 | SMARTDOP XT | JOP | Substantially Equivalent | Koven Technology, Inc. | accessdata.fda.gov |
| April 15, 2005 | K050601 | SMARTDOP 45 VASCULAR DOPPLER | DPW | Substantially Equivalent | Koven Technology, Inc. | accessdata.fda.gov |
| October 31, 1996 | K963274 | V-LINK 3.2 FOR WINDOWS | IYO | Substantially Equivalent | Koven Technology, Inc. | accessdata.fda.gov |
| March 29, 1996 | K954397 | BIDIRECTIONAL DOPPLER W/WAVEFORM DISPLAY | DPW | Substantially Equivalent | Koven Technology, Inc. | accessdata.fda.gov |
| May 11, 1995 | K935994 | PW DOPPLER VASCULAR PROBES | ITX | Substantially Equivalent | Koven Technology, Inc. | accessdata.fda.gov |
| December 23, 1994 | K942613 | SMARTDOP 30 BI-DIRECTIONAL BLOOD FLOW DETECTOR | DPW | Substantially Equivalent | Koven Technology, Inc. | accessdata.fda.gov |
| May 13, 1994 | K934638 | REUSABLE CW DOPPLER PROBES: MODELS P8M05S8A, P8M05N5A, & LCW-8 | JOP | Substantially Equivalent | Koven Technology, Inc. | accessdata.fda.gov |
| December 10, 1992 | K915550 | MINI DOPPLER II ULTRASOUND BLOOD FLOW DETECTOR | DPW | Substantially Equivalent | Koven and Assoc., Inc. | accessdata.fda.gov |
| December 23, 1991 | K912409 | MODEL HD-207 BIDIRECTIONAL VELOCITY METER | JOP | Substantially Equivalent | Koven and Assoc., Inc. | accessdata.fda.gov |
| July 16, 1984 | K840542 | MINI-DOPPLER ES-100 | JOP | Substantially Equivalent | Hayashi Denki Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Transducer, Ultrasonic
- All makers of Flowmeter, Blood, Cardiovascular
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of System, Imaging, Pulsed Doppler, Ultrasonic
- All makers of Monitor, Ultrasonic, Nonfetal
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
Updated January 5, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.