Pul-Tron 100K Professional Spirometer
FDA 510(k) K891672 · Advanced Medical Systems, Inc.
510(k) numberK891672
Submission
- Device name
- Pul-Tron 100K Professional Spirometer
- Applicant
- Advanced Medical Systems, Inc.
Minneapolis, MN, US - Received
- March 21, 1989
- Decision date
- June 16, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BZG – Spirometer, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1840
- Specialty
- Anesthesiology
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| K222525 | Alveoair Digital SpirometerBZG · Traditional | Roundworks Technologies Private Limited | 08/28/2023SE |
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| K213872 | ComPAS2BZG · Traditional | Morgan Scientific, Inc. | 07/15/2022SE |
| K212938 | Vitalograph Model 6000 AlphaBZG · Traditional | Vitalograph Ireland, Ltd. | 01/26/2022SE |
More from Vitalograph Ireland, Ltd.
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| K955931 | Model IM77 Intrapartum Fetal Monitor (Modification)HGM · Traditional | 08/14/1996SE |
| K952031 | Ultrasound Transducer, Model US917HGL · Traditional | 07/18/1995SE |
| K940898 | Model IM77 Intrapartum Fetal MonitorHGM · Traditional | 03/01/1995SE |
| K923335 | Ultrasound Transucer, Model US915 -- ModificationHGL · Traditional | 07/22/1994SE |
| K932278 | PFM Professional 7000 SpirometerBTY · Traditional | 12/17/1993SE |
| K911657 | Fetal Scalp Spiral ElectrodeHGP · Traditional | 07/11/1991SE |
| K902190 | Fetal Pulse Detector Model DOP-1HEK · Traditional | 10/22/1990SE |
| K894568 | New RAD-8 Treatment Planning Computer SystemKPQ · Traditional | 01/09/1990SE |
| K880756 | Model PM-20A Physiological MonitorDQA · Traditional | 09/27/1988SE |
Questions and answers
When was Pul-Tron 100K Professional Spirometer cleared by the FDA?
Pul-Tron 100K Professional Spirometer (K891672) received a 510(k) decision of Substantially Equivalent on June 16, 1989, 87 days after the submission was received.
What is the product code of K891672?
The FDA product code is BZG – Spirometer, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 868.1840.