FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
EKG TRANSMITTER MODEL 5134
K Number: K842051
·
Decision Mar 1, 1985
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
460
Applicant Total
32
Review Days
283
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Basic Information
- Device Name
- EKG TRANSMITTER MODEL 5134
- K Number
- K842051
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.3610
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Instromedix, Inc.
- Date Received
- May 22, 1984
- Decision Date
- March 1, 1985
- Product Code
- DXY
- 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 |
|---|---|---|---|
| DXY | Implantable Pacemaker Pulse-Generator | FDA class 3 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DXY), ordered by most recent decision date.
PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A
FDA 510(k)
FDA Class 3
·Cardiovascular
OPUS S MODEL 4121 AND 4124 PACEMAKERS
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FDA Class 3
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PIKOS LP 01, PIKOS LP E01
FDA 510(k)
FDA Class 3
·Cardiovascular
ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION)
FDA 510(k)
FDA Class 3
·Cardiovascular
MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION)
FDA 510(k)
FDA Class 3
·Cardiovascular
MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS
FDA 510(k)
FDA Class 3
·Cardiovascular
Other Clearances by Instromedix, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K964408 | POSEIDON CARDIAC MONITORING SYSTEM (PCMS) | Jul 23, 1997 | Substantially Equivalent |
| K964036 | CARDIOMAGIC 2000 SOFTWARE | Jul 18, 1997 | Substantially Equivalent |
| K955060 | ACCELERATED TRANSMISSION PROTOCOL | Apr 8, 1996 | Substantially Equivalent |
| K951096 | LIFESIGNS RECEIVING CENER 2000 TRANSTELEPHONIC RECEIVER | Jan 16, 1996 | Substantially Equivalent |
| K945476 | HEARTHWATCH III(TM) | Nov 9, 1995 | Substantially Equivalent |
| K950003 | CARDIOMAGIC(R) SOFTWARE ENHANCEMENTS | Oct 31, 1995 | Substantially Equivalent |
| K944362 | HEARTCARD CARDIAC EVENT MONITOR | Sep 7, 1995 | Substantially Equivalent |
| K943931 | CARRYALL ENHANCEMENTS | Apr 4, 1995 | Substantially Equivalent |
| K935586 | PRINCE | Nov 8, 1994 | Substantially Equivalent |
| K925639 | CARDIOMAGIC SOFTWARE | Jun 22, 1993 | Substantially Equivalent |