FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL 37 UTERINE CONTRACTION ACTIVITY MONITOR
K Number: K894030
·
Decision Jan 22, 1990
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
22
Applicant Total
35
Review Days
230
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Basic Information
- Device Name
- MODEL 37 UTERINE CONTRACTION ACTIVITY MONITOR
- K Number
- K894030
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.2720
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Healthdyne, Inc.
- Date Received
- June 6, 1989
- Decision Date
- January 22, 1990
- Product Code
- HFM
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HFM | Monitor, Uterine Contraction, External (For Use In Clinic) | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HFM), ordered by most recent decision date.
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TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING
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TOCO LITE, MODEL TD-01
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SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565
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FDA Class 2
·Obstetrics/Gynecology
TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
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 |
| K892006 | HEALTHDYNE'S APNEA/HEART MONITOR, MODEL 900S | May 23, 1989 | Substantially Equivalent |
| K890150 | H-3000 OXYGEN CONCENTRATOR | Jan 31, 1989 | Substantially Equivalent |