FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MITYVAC
K Number: K980212
·
Decision Jul 9, 1998
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
29
Applicant Total
5
Review Days
169
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Basic Information
- Device Name
- MITYVAC
- K Number
- K980212
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4340
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Prism Technologies, Inc.
- Date Received
- January 21, 1998
- Decision Date
- July 9, 1998
- Product Code
- HDB
- 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 |
|---|---|---|---|
| HDB | Extractor, Vacuum, Fetal | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
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Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum Delivery System, OmniCup® with Traction Force Indicator (VAC-DUAL MT); Kiwi® Complete Vacuum Delivery System, OmniC Cup® for Cesarean Section (VAC-DUAL C); Kiwi® Complete Vacuum Delivery System, ProCup® (VAC-DUAL S)
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MITYVAC MERLIN, MODEL 10027
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SWIFT LOW PROFILE CUP (PRO CUP)
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