FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FLEISCHMAN-SWARTZ ENDO-OCULAR PROBE
K Number: K840590
·
Decision May 9, 1984
Classifications
1
FEI Numbers
60
Registration Numbers
61
Same Product Code
179
Applicant Total
23
Review Days
90
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Basic Information
- Device Name
- FLEISCHMAN-SWARTZ ENDO-OCULAR PROBE
- K Number
- K840590
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4390
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Hgm, Inc.
- Date Received
- February 9, 1984
- Decision Date
- May 9, 1984
- Product Code
- HQF
- Advisory Committee
- Ophthalmic
- 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 |
|---|---|---|---|
| HQF | Laser, Ophthalmic | FDA class 2 | Ophthalmic |
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Other Clearances by Hgm, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K950120 | SMART PLUG | Aug 11, 1995 | Substantially Equivalent |
| K931072 | HGM ILLUMINATING/ASPIRATING ENDOOCULAR PROBE | Nov 10, 1994 | Substantially Equivalent |
| K931784 | HGM ILLUMINATING IMAGING ENDOCULAR PROBE | Mar 1, 1994 | Substantially Equivalent |
| K933333 | HGM SCANMAN PLUS | Sep 23, 1993 | Substantially Equivalent |
| K931499 | Q-11 OPHTHALMIC LASER | Aug 19, 1993 | Substantially Equivalent |
| K925663 | HGM ASPIRATING ENDOOCULAR(TM) PROBE | Aug 17, 1993 | Substantially Equivalent |
| K930543 | E-25 KRYPTON ION LASER (SURGICA K5) | Jun 22, 1993 | Substantially Equivalent |
| K880908 | MODEL PC ARGON LASER | May 3, 1988 | Substantially Equivalent |
| K873773 | ENDOCOAGULATOR MODELS 8 AND 20 ARGON LASER | Oct 13, 1987 | Substantially Equivalent |
| K872630 | ENDOCOAGULATOR(TM) MODEL 20 ARGON LASER FOR UROLO. | Aug 25, 1987 | Substantially Equivalent |