FDA 510(k)
Substantially Equivalent
🇺🇸 United States
MAC SERIES ELECTROCARDIOGRAPHS INCLUDING MAC 5000, MAC PC, MAC 6, MAC VU, MAC 8 ELECTROCARDIOGRAPHS
K Number: K991735
·
Decision Aug 19, 1999
Classifications
0
FEI Numbers
11
Registration Numbers
11
Same Product Code
82
Applicant Total
33
Review Days
90
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Basic Information
- Device Name
- MAC SERIES ELECTROCARDIOGRAPHS INCLUDING MAC 5000, MAC PC, MAC 6, MAC VU, MAC 8 ELECTROCARDIOGRAPHS
- K Number
- K991735
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- General Electric Medical Systems Information Techn
- Date Received
- May 21, 1999
- Decision Date
- August 19, 1999
- 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 General Electric Medical Systems Information Techn
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|---|---|---|---|
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| K020290 | DASH 3000/4000 PATIENT MONITOR | Aug 14, 2002 | Substantially Equivalent |
| K021366 | MAC-LAB/CARDIOLAB EP/COMBOLAB | Jul 3, 2002 | Substantially Equivalent |
| K020661 | UNITY IS PATIENT VIEWER | May 24, 2002 | Substantially Equivalent |
| K021325 | MODIFICATION OF APEXPRO TELEMETRY SYSTEM | May 7, 2002 | Substantially Equivalent |
| K020524 | PATIENTNET MONITORING SYSTEM | Mar 20, 2002 | Substantially Equivalent |
| K012467 | SOLAR 8000M SYSTEM | Feb 11, 2002 | Substantially Equivalent |