Ultrasonic Flowmeter
FDA 510(k) K800087 · The Perkin-Elmer Corp.
510(k) numberK800087
Submission
- Device name
- Ultrasonic Flowmeter
- Applicant
- The Perkin-Elmer Corp.
Mchenry, IL, US - Received
- January 14, 1980
- Decision date
- March 19, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BXP – Transducer, Gas Flow
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.2885
- Specialty
- Anesthesiology
Other 510(k)s with product code BXP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K936141 | Unipower Rechargeable Battery PackBXP · Traditional | Unipower Corp. | 03/31/1994SE |
| K920360 | Timox Oxygen TimerBXP · Traditional | Medical Fittings, Inc. | 08/03/1992SE |
| K832678 | Phonatory Function Analyzer PS-77BXP · Traditional | Kells Medical, Inc. | 03/07/1984SE |
| K781039 | Oxy-On Digital Oxygen TimerBXP · Traditional | Chambers & Sadler Mfg. | 08/31/1978SE |
| K770424 | Oxygen Twmer, Model SSTBXP · Traditional | Timeter Instrument Corp. | 03/16/1977SE |
| K761260 | Arizona Oxygen Timer DeviceBXP · Traditional | The John Bunn Co. | 12/16/1976SE |
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| K871550 | PFI-20 Polarizing FluorimeterKHO · Traditional | 07/01/1987SE |
| K872122 | 8000 Series Gas ChromatographsKZQ · Traditional | 06/17/1987SE |
| K870661 | Lifewatch PlusBZQ · Traditional | 03/09/1987SE |
| K862605 | Modular Mass Spectrometer (M.S.)CCK · Traditional | 08/13/1986SE |
Questions and answers
When was Ultrasonic Flowmeter cleared by the FDA?
Ultrasonic Flowmeter (K800087) received a 510(k) decision of Substantially Equivalent on March 19, 1980, 65 days after the submission was received.
What is the product code of K800087?
The FDA product code is BXP – Transducer, Gas Flow, a Class I (low risk) device regulated under 21 CFR 868.2885.