Apta-Bronchoscreen
FDA 510(k) K843852 · Erich Jaeger, Inc.
510(k) numberK843852
Submission
- Device name
- Apta-Bronchoscreen
- Applicant
- Erich Jaeger, Inc.
Mchenry, IL, US - Received
- October 1, 1984
- Decision date
- November 1, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BZC – Calculator, Pulmonary Function Data
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1880
- Specialty
- Anesthesiology
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| K021138 | Sleepscreen/Apnoescreen CardioMNR · Traditional | 02/12/2003SE |
| K000396 | Apnoescreen Pro, Alpha Screen ProMNR · Traditional | 12/27/2000SE |
| K001502 | Aerosol Provocation System Aps Pro, Model Aps ProBZC · Special | 07/12/2000SE |
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| K980876 | Asthma Monitor AM2BZG · Traditional | 08/14/1998SE |
| K972419 | Toennies Neuroscreen SystemIKN · Traditional | 04/30/1998SE |
| K960078 | Asthma MonitorBZG · Traditional | 09/20/1996SE |
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Questions and answers
When was Apta-Bronchoscreen cleared by the FDA?
Apta-Bronchoscreen (K843852) received a 510(k) decision of Substantially Equivalent on November 1, 1984, 31 days after the submission was received.
What is the product code of K843852?
The FDA product code is BZC – Calculator, Pulmonary Function Data, a Class II (moderate risk) device regulated under 21 CFR 868.1880.