FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
XTAL X-150 OPERATING MICROSCOPE
K Number: K853855
·
Decision Oct 15, 1985
Classifications
1
FEI Numbers
59
Registration Numbers
59
Same Product Code
13
Applicant Total
3
Review Days
29
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
- XTAL X-150 OPERATING MICROSCOPE
- K Number
- K853855
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4700
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Xtal Corp.
- Date Received
- September 16, 1985
- Decision Date
- October 15, 1985
- Product Code
- HRM
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| HRM | Microscope, Operating & Accessories, Ac-Powered, Ophthalmic | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HRM), ordered by most recent decision date.
HM-0970
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MARCO SURGISCOPE OPERATION MICROSCOPES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ALCON OPERATING MICROSCOPES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
KEELER KONAN SPECULAR MICROSCOPE SP5500
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
S 22 INSTRUMENT STAND
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MICROSCOPE KNOB COVER, STERILE, DISPOSABLE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery