Adidyne 3000
FDA 510(k) K771707 · Timeter Instrument Corp.
510(k) numberK771707
Submission
- Device name
- Adidyne 3000
- Applicant
- Timeter Instrument Corp.
Mchenry, IL, US - Received
- September 9, 1977
- Decision date
- September 26, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BTI – Compressor, Air, Portable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.6250
- Specialty
- Anesthesiology
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| K864836 | L.A.P. SpirometerBTY · Traditional | 03/06/1987SE |
| K834274 | Criterion ICAW · Traditional | 04/13/1984SE |
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| K822746 | RT-200 Calibration AnalyzerBXX · Traditional | 10/13/1982SE |
| K812766 | PCS-5 AccessoriesBTI · Traditional | 12/17/1981SE |
| K813235 | Diss Female Air AdaptorBYK · Traditional | 12/08/1981SE |
| K813234 | Ohio Air AdaptorBYX · Traditional | 12/08/1981SE |
Questions and answers
When was Adidyne 3000 cleared by the FDA?
Adidyne 3000 (K771707) received a 510(k) decision of Substantially Equivalent on September 26, 1977, 17 days after the submission was received.
What is the product code of K771707?
The FDA product code is BTI – Compressor, Air, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.6250.