Instapure
FDA 510(k) K854817 · Teledyne, Inc.
510(k) numberK854817
Submission
- Device name
- Instapure
- Applicant
- Teledyne, Inc.
Fort Collins, CO, US - Received
- December 3, 1985
- Decision date
- February 28, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FRF – Cleaner, Air, Medical Recirculating
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5045
- Specialty
- General Hospital
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| K862695 | Fluor-Etch Gel EtchantEBC · Traditional | 07/31/1986SE |
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| K801593 | Lebody by Water PikISA · Traditional | 08/20/1980SE |
| K800919 | Oraview by Water PikEAX · Traditional | 05/08/1980SE |
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Questions and answers
When was Instapure cleared by the FDA?
Instapure (K854817) received a 510(k) decision of Substantially Equivalent on February 28, 1986, 87 days after the submission was received.
What is the product code of K854817?
The FDA product code is FRF – Cleaner, Air, Medical Recirculating, a Class II (moderate risk) device regulated under 21 CFR 880.5045.