FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SONAR-AID(R) ULTRASOUND STANDOFF PAD
K Number: K874943
·
Decision Jul 25, 1988
Classifications
1
FEI Numbers
398
Registration Numbers
399
Same Product Code
408
Applicant Total
16
Review Days
236
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Basic Information
- Device Name
- SONAR-AID(R) ULTRASOUND STANDOFF PAD
- K Number
- K874943
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1570
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Geistlich-Pharma
- Date Received
- December 2, 1987
- Decision Date
- July 25, 1988
- Product Code
- ITX
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ITX), ordered by most recent decision date.
ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)
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ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R)
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| K970569 | BIO-BLOCKS | Aug 14, 2000 | Substantially Equivalent |
| K974399 | BIO-OSS COLLAGEN | Sep 16, 1998 | Substantially Equivalent |
| K970321 | BIO-OSS ANORGANIC BOVINE BONE | Sep 15, 1998 | Substantially Equivalent |
| K972817 | RESOR-PIN RESORBABLE MEMBRANE PIN | Jul 24, 1998 | Substantially Equivalent |
| K960724 | BIO-GIDE RESORBABLE BILAYER MEMBRANE | Jun 11, 1997 | Substantially Equivalent |
| K952619 | BIO-OSS CERAMIC | Aug 28, 1995 | Substantially Equivalent |
| K952618 | BIO-OSS | Aug 28, 1995 | Substantially Equivalent |
| K952617 | BIO-OSS | Aug 7, 1995 | Substantially Equivalent |