FDA 510(k)
Substantially Equivalent
🇺🇸 United States
ELITE II ELECTROCARDIOGRAPH,MODIFIED
K Number: K915327
·
Decision Oct 9, 1992
Classifications
0
FEI Numbers
11
Registration Numbers
11
Same Product Code
82
Applicant Total
7
Review Days
318
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Basic Information
- Device Name
- ELITE II ELECTROCARDIOGRAPH,MODIFIED
- K Number
- K915327
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Siemens Burdick, Inc.
- Date Received
- November 26, 1991
- Decision Date
- October 9, 1992
- 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 Siemens Burdick, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K915225 | MEGACART | Jul 1, 1992 | Substantially Equivalent |
| K915202 | INTERNAL MODEM FOR THE E560 ELECTROCARDIOGRAPH | May 15, 1992 | Substantially Equivalent |
| K914969 | E350I ELECTROCARDIOGRAPH | Mar 26, 1992 | Substantially Equivalent |
| K913518 | TA620 TREADMILL CONTROLLER | Oct 24, 1991 | Substantially Equivalent |
| K910634 | DC200 DEFIBRILLATOR | Jul 24, 1991 | Substantially Equivalent |
| K910867 | T600 TREADMILL | May 31, 1991 | Substantially Equivalent |