FDA 510(k)
Substantially Equivalent
🇺🇸 United States
CARDIOSMART ST
K Number: K973403
·
Decision Mar 12, 1998
Classifications
0
FEI Numbers
11
Registration Numbers
11
Same Product Code
82
Applicant Total
9
Review Days
184
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Basic Information
- Device Name
- CARDIOSMART ST
- K Number
- K973403
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Marquette Medical Systems, Inc.
- Date Received
- September 9, 1997
- Decision Date
- March 12, 1998
- Product Code
- LOS
- Advisory Committee
- Unknown
- Review Advisory Committee
- CV
- Third Party
- N
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LOS), ordered by most recent decision date.
Other Clearances by Marquette Medical Systems, Inc.
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|---|---|---|---|
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| K981024 | QT DISPERSION AND T WAVE ANALYSIS PROGRAM (QT GUARD ANALYSIS SYSTEM) | Oct 6, 1998 | Substantially Equivalent |
| K980495 | MUSE CARDIOVASCULAR INFORMATION SYSTEM | May 7, 1998 | Substantially Equivalent |
| K980299 | APEX OXIMETER | Apr 24, 1998 | Substantially Equivalent |
| K980582 | MULTI-LINK CABLE AND LEAD WIRE SYSTEMS | Mar 16, 1998 | Substantially Equivalent |
| K974199 | ACUTE CARDIAC ISCHEMIA TIME-INSENSITIVE PREDICTIVE INSTRUMENT (ACI-TIPI) OPTION | Feb 6, 1998 | Substantially Equivalent |
| K973984 | RAC 2A MODULE HOUSING | Jan 16, 1998 | Substantially Equivalent |
| K970545 | DASH 1000 PATIENT MONITOR | May 8, 1997 | Substantially Equivalent |