PTT-200 Telephonic Pulmonary Transmitt
FDA 510(k) K812849 · Pharmaquest Corp.
510(k) numberK812849
Submission
- Device name
- PTT-200 Telephonic Pulmonary Transmitt
- Applicant
- Pharmaquest Corp.
Mchenry, IL, US - Received
- October 9, 1981
- Decision date
- December 3, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BTY – Calculator, Predicted Values, Pulmonary Function
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1890
- Specialty
- Anesthesiology
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| K945519 | Face (Fluorophore-Assisted-Carbohydrate-Electrophoresis) Urinary Carbohydrate Analysis…MPG · Traditional | 11/03/1995SE |
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| K833236 | Telephone Transmitter T-10 EEGGYE · Traditional | 11/29/1983SE |
| K830705 | Mini Lancet-Blood LancetFMA · Traditional | 04/08/1983SE |
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| K822486 | Home Blood Glucose MonitorCGA · Traditional | 11/05/1982SE |
| K820248 | Rodder Volume VentilatorCBK · Traditional | 04/16/1982SE |
| K812850 | PTT-200 Pulmonary Receiver/MicroprocesBTY · Traditional | 12/03/1981SE |
| K813010 | EEG Telephone Transmitter, Model #T-7GYE · Traditional | 11/16/1981SE |
| K812683 | Neonate FlexfloatFOH · Traditional | 10/13/1981SE |
Questions and answers
When was PTT-200 Telephonic Pulmonary Transmitt cleared by the FDA?
PTT-200 Telephonic Pulmonary Transmitt (K812849) received a 510(k) decision of Substantially Equivalent on December 3, 1981, 55 days after the submission was received.
What is the product code of K812849?
The FDA product code is BTY – Calculator, Predicted Values, Pulmonary Function, a Class II (moderate risk) device regulated under 21 CFR 868.1890.