FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HOLTER RECORDER & PLAYBACK/ANALYSIS SYS
K Number: K822818
·
Decision Dec 30, 1982
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
193
Applicant Total
82
Review Days
101
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Basic Information
- Device Name
- HOLTER RECORDER & PLAYBACK/ANALYSIS SYS
- K Number
- K822818
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Marquette Electronics, Inc.
- Date Received
- September 20, 1982
- Decision Date
- December 30, 1982
- Product Code
- DSH
- 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 |
|---|---|---|---|
| DSH | Recorder, Magnetic Tape, Medical | FDA class 2 | Cardiovascular |
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|---|---|---|---|
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| K962547 | CARDIOSERV P | Mar 6, 1997 | Substantially Equivalent |
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| K962827 | ALARM DISPLAY UNIT/PAGER-LAN SYSTEM (ADU) | Feb 24, 1997 | Substantially Equivalent |
| K964750 | EAGLE 4000 PATIENT MONITOR | Feb 21, 1997 | Substantially Equivalent |
| K962551 | CARDIOSERV S | Nov 19, 1996 | Substantially Equivalent - Subject to Tracking Reg. |
| K960418 | EAGLE PATIENT MONITOR | Oct 2, 1996 | Substantially Equivalent |
| K960272 | EAGLE 3000/3100 PATIENT MONITOR | Oct 2, 1996 | Substantially Equivalent |