FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL NUMBER (TBD) TOCO DATA TELEPHONE TRANS. SYS.
K Number: K882080
·
Decision Mar 1, 1989
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
22
Applicant Total
24
Review Days
288
Basic Information
- Device Name
- MODEL NUMBER (TBD) TOCO DATA TELEPHONE TRANS. SYS.
- K Number
- K882080
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.2720
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- AEQUITRON MEDICAL, INC.
- Date Received
- May 17, 1988
- Decision Date
- March 1, 1989
- 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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SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565
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TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING
FDA 510(k)
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Other Clearances by AEQUITRON MEDICAL, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K961972 | MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITOR | Apr 18, 1997 | Substantially Equivalent - Subject to Tracking Reg. |
| K952880 | MODEL LP-1000 VOLUME VENTILATOR | Jun 20, 1996 | Substantially Equivalent - Subject to Tracking Reg. |
| K944654 | OXYGEN CONCENTRATION INDICATOR | Nov 8, 1994 | Substantially Equivalent |
| K914424 | MODEL 6213 REMOTE ALARM | Sep 10, 1992 | Substantially Equivalent |
| K915381 | PORTABLE OXYGEN GENERATOR | Mar 11, 1992 | Substantially Equivalent |
| K911399 | NASAL CPAP (CONTINUOUS POSITIVE AIR PRESSURE SYST) | Sep 19, 1991 | Substantially Equivalent |
| K903020 | RESPIRATION/HEART RATE MONITOR MODEL 9500/9550 | Apr 10, 1991 | Substantially Equivalent |
| K903010 | CONTINUOUS VOLUME VENTILATOR MODEL LP10 | Nov 30, 1990 | Substantially Equivalent |
| K905244 | MODEL LP6 VENTILATOR, MODIFICATION | Nov 30, 1990 | Substantially Equivalent |
| K901656 | MODEL 9200 RESPIRATION/HEART RATE MONITOR | Jul 13, 1990 | Substantially Equivalent |