Transfer Device
FDA 510(k) K853188 · Advance Medical Designs, Inc.
510(k) numberK853188
Submission
- Device name
- Transfer Device
- Applicant
- Advance Medical Designs, Inc.
Marietta, GA, US - Received
- July 30, 1985
- Decision date
- August 21, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LHI – Set, I.V. Fluid Transfer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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| K012168 | Advance Medical Designs Fluid PouchKKX · Traditional | 09/18/2001SE |
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| K925115 | Amd Dentist and Hygienist KitsEKJ · Traditional | 07/05/1994SE |
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Questions and answers
When was Transfer Device cleared by the FDA?
Transfer Device (K853188) received a 510(k) decision of Substantially Equivalent on August 21, 1985, 22 days after the submission was received.
What is the product code of K853188?
The FDA product code is LHI – Set, I.V. Fluid Transfer, a Class II (moderate risk) device regulated under 21 CFR 880.5440.