FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
O-020 LASER INDIRECT OPHTHALMOSCOPE
K Number: K890787
·
Decision Mar 24, 1989
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
3
Applicant Total
18
Review Days
37
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Basic Information
- Device Name
- O-020 LASER INDIRECT OPHTHALMOSCOPE
- K Number
- K890787
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5070
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Hgm Medical Laser Systems, Inc.
- Date Received
- February 15, 1989
- Decision Date
- March 24, 1989
- Product Code
- HGF
- 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 |
|---|---|---|---|
| HGF | Source, Abortion Unit, Vacuum | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HGF), ordered by most recent decision date.
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FDA Class 2
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MODEL GLASE 210 HOLMIUM LASER SYSTEM
FDA 510(k)
FDA Class 2
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Other Clearances by Hgm Medical Laser Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K921300 | MODEL PC ARGON ION LASER | Oct 6, 1992 | Substantially Equivalent |
| K914484 | LITESPOT(TM) LASER INDIRECT OPHTHALMOSCOPE | Jan 6, 1992 | Substantially Equivalent |
| K913569 | COMPAC A, ELITE A, ELITE A PLUS, SURGICA A | Oct 17, 1991 | Substantially Equivalent |
| K912628 | AIR ARGON ION LASERS VARIOUS MODELS | Sep 13, 1991 | Substantially Equivalent |
| K910272 | HGM COMBINATION ND:YAG & SOLID STATE GREEN | Aug 9, 1991 | Substantially Equivalent |
| K912438 | MODELS 5,8,20,20S ARGON ION LASERS | Jul 17, 1991 | Substantially Equivalent |
| K910602 | HGM ARGON ION & SOLID LIGHT LASER FOR DENTISTRY | Jun 24, 1991 | Substantially Equivalent |
| K911104 | PHOTCOAGULATOR KR-568 LASER SPECTRUM ELITE K1 | Jun 11, 1991 | Substantially Equivalent |
| K910898 | SURGICA(TM) H | May 31, 1991 | Substantially Equivalent |
| K904699 | COMPAC(TM) DIODE LASERS | Apr 25, 1991 | Substantially Equivalent |