FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
BIO-PEN CALCULATOR
K Number: K860205
·
Decision Apr 24, 1986
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
1
Applicant Total
7
Review Days
92
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Basic Information
- Device Name
- BIO-PEN CALCULATOR
- K Number
- K860205
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Oculab, Inc.
- Date Received
- January 22, 1986
- Decision Date
- April 24, 1986
- Product Code
- LQB
- Advisory Committee
- Unknown
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| LQB | Medical Computers And Software For Ophthalmic Use | FDA class 3 | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LQB), ordered by most recent decision date.
View allOther Clearances by Oculab, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K884619 | PACH-PEN CALCULATOR | Feb 2, 1989 | Substantially Equivalent |
| K882750 | OCU-FILM TIP COVER | Aug 4, 1988 | Substantially Equivalent |
| K862016 | PACH-PEN SURGICAL DRAPE | Jun 4, 1986 | Substantially Equivalent |
| K860061 | OCULAB BIOMETRICPEN | Mar 10, 1986 | Substantially Equivalent |
| K860062 | OCULAB PACHPEN | Mar 10, 1986 | Substantially Equivalent |
| K852774 | OCULAB TONOPEN | Aug 20, 1985 | Substantially Equivalent |