FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WRIST BLOOD PRESSURE METER MODEL SE-330
K Number: K973078
·
Decision May 20, 1999
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
136
Applicant Total
12
Review Days
640
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- WRIST BLOOD PRESSURE METER MODEL SE-330
- K Number
- K973078
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2100
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sein Electronics Co., Ltd.
- Date Received
- August 18, 1997
- Decision Date
- May 20, 1999
- Product Code
- DPW
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DPW | Flowmeter, Blood, Cardiovascular | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DPW), ordered by most recent decision date.
FloPatch FP120
FDA 510(k)
FDA Class 2
·Cardiovascular
VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-SP-01, VC-SD-01)
FDA 510(k)
FDA Class 2
·Cardiovascular
FloPatch FP120
FDA 510(k)
FDA Class 2
·Cardiovascular
Elfor-L
FDA 510(k)
FDA Class 2
·Cardiovascular
VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-SP-01, VC-CH-01)
FDA 510(k)
FDA Class 2
·Cardiovascular
FloPatch FP120
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Sein Electronics Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K052108 | SEIN BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM, MODEL BGP-100 | Dec 7, 2005 | Substantially Equivalent |
| K042138 | FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR MODEL# SE-311 | Aug 24, 2004 | Substantially Equivalent |
| K042014 | DIGITAL BLOOD PRESSURE MONITOR, MODELS SE-9000, SE-9200 AND SE-9400 | Aug 6, 2004 | Substantially Equivalent |
| K032927 | FULL AUTO ARM DIGITAL BLOOD PRESSURE MONITOR | May 7, 2004 | Substantially Equivalent |
| K012054 | FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL SE-312 | Aug 8, 2001 | Substantially Equivalent |
| K003711 | AMBULATORY BLOOD PRESSURE MONITORING SYSTEM, MODEL SE-25M/25P | Dec 15, 2000 | Substantially Equivalent |
| K003282 | FULL AUTO BLOOD PRESSURE MONITOR, MODEL SE-7700H | Nov 1, 2000 | Substantially Equivalent |
| K991397 | TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR SE-30 TENS | Feb 11, 2000 | Substantially Equivalent |
| K952826 | FULL AUTO FUZZY BLOOD PRESSURE METER MODEL SE-7000 | Nov 14, 1996 | Substantially Equivalent |
| K952827 | FULL AUTO WRIST BLOOD PRESSURE METER MODEL SE-5000 | Nov 14, 1996 | Substantially Equivalent |