FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL {M-102 I-CHANNEL ELECTRO CARDIOGRAPH UNIT
K Number: K843934
·
Decision Nov 20, 1984
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
574
Applicant Total
14
Review Days
42
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
- MODEL {M-102 I-CHANNEL ELECTRO CARDIOGRAPH UNIT
- K Number
- K843934
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Future Impex Corp.
- Date Received
- October 9, 1984
- Decision Date
- November 20, 1984
- Product Code
- DPS
- 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 |
|---|---|---|---|
| DPS | Electrocardiograph | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DPS), ordered by most recent decision date.
MAC 7 Resting ECG Analysis System
FDA 510(k)
FDA Class 2
·Cardiovascular
AccurECG Analysis System (v2.0)
FDA 510(k)
FDA Class 2
·Cardiovascular
Withings BeamO (SCT02)
FDA 510(k)
FDA Class 2
·Cardiovascular
Cardiologs Holter Platform
FDA 510(k)
FDA Class 2
·Cardiovascular
ZBPro Diagnostic
FDA 510(k)
FDA Class 2
·Cardiovascular
Masimo W1
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Future Impex Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K861487 | ST-90 SPIRO ANALIZER | Jun 23, 1986 | Substantially Equivalent |
| K854686 | TE-25 COAGURO METER | Jun 4, 1986 | Substantially Equivalent |
| K854687 | ERMA HB-METER MODEL 303N | Jun 4, 1986 | Substantially Equivalent |
| K854685 | DIGITAL-9 KEY LEUCOCYTE COUNTER | Apr 4, 1986 | Substantially Equivalent |
| K854678 | ERMA PC-602 PC-603 BLOOD CELL COUNTER | Feb 24, 1986 | Substantially Equivalent |
| K854677 | ERMA PC-604 BLOOD CELL COUNTER | Feb 24, 1986 | Substantially Equivalent |
| K854679 | PHOTIC-100 SPECTROPHOTOMETER | Feb 20, 1986 | Substantially Equivalent |
| K843984 | PM-80 PULMOTESTER | Oct 24, 1984 | Substantially Equivalent |
| K843700 | ST-200A W/MAXIMAL VOLUNTARY VENTILLAT- | Oct 24, 1984 | Substantially Equivalent |
| K832433 | AUTOMATIC SPIROMETER ST-200 | Sep 29, 1983 | Substantially Equivalent |