FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL 900S APNEA/HEART MONITOR
K Number: K903287
·
Decision Aug 17, 1990
Classifications
1
FEI Numbers
109
Registration Numbers
109
Same Product Code
174
Applicant Total
35
Review Days
37
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Basic Information
- Device Name
- MODEL 900S APNEA/HEART MONITOR
- K Number
- K903287
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2375
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Healthdyne, Inc.
- Date Received
- July 11, 1990
- Decision Date
- August 17, 1990
- Product Code
- BZQ
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| BZQ | Monitor, Breathing Frequency | FDA class 2 | Anesthesiology |
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Other Clearances by Healthdyne, Inc.
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|---|---|---|---|
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| 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 |
| 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 |
| K890150 | H-3000 OXYGEN CONCENTRATOR | Jan 31, 1989 | Substantially Equivalent |