Spirocal
FDA 510(k) K791294 · Equilibrated Bio Systems, Inc.
510(k) numberK791294
Submission
- Device name
- Spirocal
- Applicant
- Equilibrated Bio Systems, Inc.
Mchenry, IL, US - Received
- July 10, 1979
- Decision date
- August 16, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BXX – Calibrator, Pressure, Gas
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.2620
- Specialty
- Anesthesiology
Other 510(k)s with product code BXX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K923397 | Single Dose Gas InjectorBXX · Traditional | Escalon Medical Trek | 09/14/1992SE |
| K875075 | RT-200 Computer InterfaceBXX · Traditional | Timeter Instrument Corp. | 04/21/1988SE |
| K850029 | Utah Pressure Transducer Calibrator Tru-CalBXX · Traditional | Utah Medical Products, Inc. | 04/29/1985SE |
| K822746 | RT-200 Calibration AnalyzerBXX · Traditional | Timeter Instrument Corp. | 10/13/1982SE |
| K801258 | Needle Counter-Sure COUNT/10 CountBXX · Traditional | Kleen Test Products | 06/04/1980SE |
| K801257 | Needle Counter-Sure COUNT/30 Ct. Magn.BXX · Traditional | Kleen Test Products | 06/04/1980SE |
| K801256 | Needle Counter-Sure Count-Disposa-TrayBXX · Traditional | Kleen Test Products | 06/04/1980SE |
| K780981 | Portable Pneumatic Calibrator 65-150BXX · Traditional | Pennwalt Corp. | 08/02/1978SE |
| K780838 | PerciBXX · Traditional | Micro Tronics Corp. | 07/17/1978SE |
More from Micro Tronics Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K892705 | EBS2605 Infant HuggerBTY · Traditional | 10/27/1989SE |
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| K843996 | Turboaire Challanger Environmental Air ControllerBZG · Traditional | 11/20/1984SE |
| K790410 | Adult Zee-FrameJAY · Traditional | 03/22/1979SE |
| K781509 | Zee-FrameJAY · Traditional | 09/26/1978SE |
| K781386 | Ebs 775 TonometerLCH · Traditional | 09/14/1978SE |
Questions and answers
When was Spirocal cleared by the FDA?
Spirocal (K791294) received a 510(k) decision of Substantially Equivalent on August 16, 1979, 37 days after the submission was received.
What is the product code of K791294?
The FDA product code is BXX – Calibrator, Pressure, Gas, a Class I (low risk) device regulated under 21 CFR 868.2620.