FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEALTHDYNE APNEA/HEART MONITOR, MODEL 900
K Number: K874695
·
Decision Jan 29, 1988
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
338
Applicant Total
35
Review Days
74
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Basic Information
- Device Name
- HEALTHDYNE APNEA/HEART MONITOR, MODEL 900
- K Number
- K874695
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Healthdyne, Inc.
- Date Received
- November 16, 1987
- Decision Date
- January 29, 1988
- Product Code
- DRT
- 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 |
|---|---|---|---|
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | FDA class 2 | Cardiovascular |
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Other Clearances by Healthdyne, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K950331 | PRESSURE SUPPORT VENTILATORY ASSIST SYSTEM (PSVAS) | Sep 21, 1995 | Substantially Equivalent |
| K922106 | ALICE | Jul 6, 1994 | Substantially Equivalent |
| K942357 | H-500 ALLIANCE OXYGEN CONCENTRATOR | May 27, 1994 | Substantially Equivalent |
| K934502 | FLOW SPIROMETER | Apr 4, 1994 | Substantially Equivalent |
| K924146 | OH-500 OXYGEN CONCENTRATOR | Jan 7, 1993 | Substantially Equivalent |
| K922623 | NEBULIZER SYSTEM | Dec 1, 1992 | Substantially Equivalent |
| K910118 | DATA RECORDER | Feb 14, 1991 | Substantially Equivalent |
| K903287 | MODEL 900S APNEA/HEART MONITOR | Aug 17, 1990 | Substantially Equivalent |
| K894030 | MODEL 37 UTERINE CONTRACTION ACTIVITY MONITOR | Jan 22, 1990 | Substantially Equivalent |
| K892006 | HEALTHDYNE'S APNEA/HEART MONITOR, MODEL 900S | May 23, 1989 | Substantially Equivalent |