Ultrasonic Couplant Gel
FDA 510(k) K854996 · Johnson & Johnson Professionals, Inc.
510(k) numberK854996
Submission
- Device name
- Ultrasonic Couplant Gel
- Applicant
- Johnson & Johnson Professionals, Inc.
Ramsey, NJ, US - Received
- December 12, 1985
- Decision date
- April 14, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JOP – Transducer, Ultrasonic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2880
- Specialty
- Cardiovascular
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| K002766 | Nicolet VasoguardJOP · Abbreviated | Nicolet Biomedical | 11/30/2000SE |
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Questions and answers
When was Ultrasonic Couplant Gel cleared by the FDA?
Ultrasonic Couplant Gel (K854996) received a 510(k) decision of Substantially Equivalent on April 14, 1986, 123 days after the submission was received.
What is the product code of K854996?
The FDA product code is JOP – Transducer, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 870.2880.