FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GRAHAM-FIELD ULTRASOUND LOTION
K Number: K944596
·
Decision Jun 7, 1995
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
88
Applicant Total
11
Review Days
261
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Basic Information
- Device Name
- GRAHAM-FIELD ULTRASOUND LOTION
- K Number
- K944596
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5300
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Chester Labs, Inc.
- Date Received
- September 19, 1994
- Decision Date
- June 7, 1995
- Product Code
- IMI
- Advisory Committee
- Physical Medicine
- 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 |
|---|---|---|---|
| IMI | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | FDA class 2 | Physical Medicine |
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Other Clearances by Chester Labs, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K041060 | E-Z LUBRICATING JELLY | May 7, 2004 | Substantially Equivalent |
| K001705 | STATSIGN ELECTRODE CONDUCTIVITY GEL, GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL, MODELS 004008, 48-4000 2GF, 48-4000GF | Jun 29, 2000 | Substantially Equivalent |
| K001593 | MODIFICATION TO STATSIGN SALINE ELECTROLYTE GEL, GRAHAM-FIELD SALINE ELECTROLYTE GEL | Jun 14, 2000 | Substantially Equivalent |
| K944599 | GRAHAM-FIELD CONDUCTIVE ECG SPRAY | May 7, 1996 | Substantially Equivalent |
| K944598 | GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL | May 7, 1996 | Substantially Equivalent |
| K944600 | GRAHAM-FIELD SALINE ELECTROLYTE GEL | Nov 20, 1995 | Substantially Equivalent |
| K944597 | GRAHAM-FIELD ULTRASOUND SCANNING GEL | Jun 21, 1995 | Substantially Equivalent |
| K940254 | BIOSHIELD BLUE POWDER FREE GLOVE | Mar 23, 1994 | Substantially Equivalent |
| K940256 | BIOSHIELD BLUE LATEX GLOVES | Mar 23, 1994 | Substantially Equivalent |
| K841871 | LIQUA-SONIC GEL | Mar 14, 1985 | Substantially Equivalent |