FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565
K Number: K994353
·
Decision Mar 22, 2000
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
22
Applicant Total
25
Review Days
90
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Basic Information
- Device Name
- SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565
- K Number
- K994353
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.2720
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Precision Dynamics Corp.
- Date Received
- December 23, 1999
- Decision Date
- March 22, 2000
- 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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DISCO UTERINE CONTRACTION TRANSDUCER & ACCESSORIES
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Other Clearances by Precision Dynamics Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K020718 | SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERILE | Jun 3, 2002 | Substantially Equivalent |
| K994263 | SECURLINE UMBILICAL CORD CLAMP CLIPPER #3540 | Jan 24, 2000 | Substantially Equivalent |
| K990737 | 'ECURLINE UMBILICAL CORD CLAMP #3500 | Apr 6, 1999 | Substantially Equivalent |
| K884357 | PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEM | Nov 1, 1988 | Substantially Equivalent |
| K882580 | MECHANICAL CHANGE IN IN-VITRO MICRO DEVICE | Jul 8, 1988 | Substantially Equivalent |
| K874665 | SECURLINE FINE NEEDLE ASPIRATION BIOPSY TRAY | Jan 20, 1988 | Unknown |
| K873369 | SECURLINE FRANSEENE NEEDLE | Oct 20, 1987 | Substantially Equivalent |
| K872507 | PRECISION CULTURE C.A.T.S. COLLECT/TRANS HSV I/II | Jul 9, 1987 | Substantially Equivalent |
| K863164 | AGAR REDUCTION IN FORMULA FOR PDC 110 & 310 MEDIA | Aug 27, 1986 | Substantially Equivalent |
| K851364 | FRANZEN NEEDLE GUIDE FOR TRANSRECTAL PROSTATE BIOP | Apr 22, 1985 | Substantially Equivalent |