FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SCMD-1000
K Number: K980985
·
Decision May 1, 1998
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
82
Applicant Total
5
Review Days
45
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SCMD-1000
- K Number
- K980985
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4370
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Howard Instruments, Inc.
- Date Received
- March 17, 1998
- Decision Date
- May 1, 1998
- Product Code
- HNO
- 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 |
|---|---|---|---|
| HNO | Keratome, Ac-Powered | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HNO), ordered by most recent decision date.
VisuMax Femtosecond Laser
FDA 510(k)
FDA Class 1
·Ophthalmic
EPI K Console
FDA 510(k)
FDA Class 1
·Ophthalmic
EPIVISION SL SYSTEM
FDA 510(k)
FDA Class 1
·Ophthalmic
CARRIAZO-PENDULAR MICROKERATOME
FDA 510(k)
FDA Class 1
·Ophthalmic
ZYOPTIX XP EPI SEPARATOR SYSTEM
FDA 510(k)
FDA Class 1
·Ophthalmic
HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM
FDA 510(k)
FDA Class 1
·Ophthalmic
Other Clearances by Howard Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K063104 | FOX MEDICAL DIODE LASER SYSTEM 810NM | May 16, 2007 | Substantially Equivalent |
| K030948 | VMATE MODEL VMM1000 | Jun 17, 2003 | Substantially Equivalent |
| K974598 | MICROKERATOME OR THE MATE | Apr 22, 1998 | Substantially Equivalent |
| K972727 | CBALK-1000 BLADE | Oct 10, 1997 | Substantially Equivalent |