Surveyor I, Respiratory Computer System
FDA 510(k) K801526 · The Devilbiss Co.
510(k) numberK801526
Submission
- Device name
- Surveyor I, Respiratory Computer System
- Applicant
- The Devilbiss Co.
Mchenry, IL, US - Received
- July 2, 1980
- Decision date
- July 21, 1980
- 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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| K150810 | Vyntus / SentrySuite Product LineBZC · Traditional | Carefusion Germany 234 GmbH | 08/14/2015SE |
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| K102047 | Lci Option for InnocorBZC · Traditional | Innovision A/S | 11/01/2011SE |
More from Innovision A/S
| 510(k) | Device | Decision |
|---|---|---|
| K874041 | Devilbiss Model 8500DCAF · Traditional | 12/23/1987SE |
| K872094 | Vacu-AideJCX · Traditional | 10/15/1987SE |
| K872826 | Ultra-Neb 99 Ultrasonic NebulizerCAF · Traditional | 09/04/1987SE |
| K872470 | DEVO/MC44 Oxygen ConcentratorCAW · Traditional | 08/03/1987SE |
| K854520 | Pulmo-Aide Model 5610DCCQ · Traditional | 12/09/1985SE |
| K852209 | DEVO/MC29 Oxygen Concentrator MC29DCAW · Traditional | 06/24/1985SE |
| K851695 | Ultra-Neb 100 Ultrasonic Nebulizer · Traditional | 06/05/1985SE |
| K830174 | De VO/44 Oxygen Concentrator #444CAW · Traditional | 02/17/1983SE |
| K792385 | Devo Oxygen Concentrator, Model 955CAW · Traditional | 12/05/1979SE |
| K781073 | Pulmo-SonicCCQ · Traditional | 09/27/1978SE |
Questions and answers
When was Surveyor I, Respiratory Computer System cleared by the FDA?
Surveyor I, Respiratory Computer System (K801526) received a 510(k) decision of Substantially Equivalent on July 21, 1980, 19 days after the submission was received.
What is the product code of K801526?
The FDA product code is BZC – Calculator, Pulmonary Function Data, a Class II (moderate risk) device regulated under 21 CFR 868.1880.