FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
BARD (R) ESKA ERECTIOMETER
K Number: K880903
·
Decision May 6, 1988
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
25
Applicant Total
645
Review Days
65
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Basic Information
- Device Name
- BARD (R) ESKA ERECTIOMETER
- K Number
- K880903
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- C.R. Bard, Inc.
- Date Received
- March 2, 1988
- Decision Date
- May 6, 1988
- Product Code
- LIL
- Advisory Committee
- Unknown
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| LIL | Monitor, Penile Tumescence | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LIL), ordered by most recent decision date.
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MONARCH 21 PENILE PLETHYSMOGRAPH SYSTEM
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DIGITAL INFLECTION RIGIDOMETER (DIR)
FDA 510(k)
FDA Unclassified
·Unknown
VISER PENILE TUMESCENCE MONITOR
FDA 510(k)
FDA Unclassified
·Unknown
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