FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARRYALL ENHANCEMENTS
K Number: K943931
·
Decision Apr 4, 1995
Classifications
1
FEI Numbers
86
Registration Numbers
86
Same Product Code
292
Applicant Total
32
Review Days
235
Basic Information
- Device Name
- CARRYALL ENHANCEMENTS
- K Number
- K943931
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2920
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- INSTROMEDIX, INC.
- Date Received
- August 12, 1994
- Decision Date
- April 4, 1995
- Product Code
- DXH
- 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 |
|---|---|---|---|
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | FDA class 2 | Cardiovascular |
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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 |
| K935586 | PRINCE | Nov 8, 1994 | Substantially Equivalent |
| K925639 | CARDIOMAGIC SOFTWARE | Jun 22, 1993 | Substantially Equivalent |
| K923221 | KING OF HEARTS SCEPTER | Mar 8, 1993 | Substantially Equivalent |