FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KING OF HEARTS SCEPTER
K Number: K923221
·
Decision Mar 8, 1993
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
574
Applicant Total
32
Review Days
250
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Basic Information
- Device Name
- KING OF HEARTS SCEPTER
- K Number
- K923221
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Instromedix, Inc.
- Date Received
- July 1, 1992
- Decision Date
- March 8, 1993
- 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 |
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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 |
| K943931 | CARRYALL ENHANCEMENTS | Apr 4, 1995 | Substantially Equivalent |
| K935586 | PRINCE | Nov 8, 1994 | Substantially Equivalent |
| K925639 | CARDIOMAGIC SOFTWARE | Jun 22, 1993 | Substantially Equivalent |