FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
KREMER BLADE GAUGE
K Number: K820050
·
Decision Feb 24, 1982
Classifications
1
FEI Numbers
162
Registration Numbers
162
Same Product Code
6
Applicant Total
8
Review Days
47
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Basic Information
- Device Name
- KREMER BLADE GAUGE
- K Number
- K820050
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4350
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Accutome, Inc.
- Date Received
- January 8, 1982
- Decision Date
- February 24, 1982
- Product Code
- HOE
- 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 |
|---|---|---|---|
| HOE | Caliper, Ophthalmic | FDA class 1 | Ophthalmic |
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| K123349 | A-SCAN PLUS CONNECT | Jan 29, 2013 | Substantially Equivalent |
| K103471 | UBM PLUS | Mar 14, 2011 | Substantially Equivalent |
| K050552 | PACHPEN PACHYMETER, MODEL 24-5100 | Mar 28, 2005 | Substantially Equivalent |
| K032956 | ACCUSONIC A-SCAN MODEL, 24-4000 | Oct 10, 2003 | Substantially Equivalent |
| K810660 | KREMER CORNEOMETER ULTRASONIC PACHOMETER | Aug 21, 1981 | Substantially Equivalent |