Blood Level Detector-Model 7601
FDA 510(k) K781330 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK781330
Submission
- Device name
- Blood Level Detector-Model 7601
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Washington, DC, US - Received
- August 2, 1978
- Decision date
- August 31, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FJF – Detector, Air Bubble
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
Other 510(k)s with product code FJF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K904992 | Minnilert Air DetectorFJF · Traditional | Minntech Corp. | 02/05/1991SE |
| K891327 | Nickle-Titanium Orthodontic WireFJF · Traditional | American Orthodontics | 05/10/1989SE |
| K780582 | Detector, Bubble & FoamFJF · Traditional | Hospal Medical Corp. | 06/22/1978SE |
| K770857 | Dialysis Machine, Centry IIFJF · Traditional | Cobe Laboratories, Inc. | 10/04/1977SE |
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| K992734 | Becton Dickinson SyringeMEG · Traditional | 10/01/1999SE |
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Questions and answers
When was Blood Level Detector-Model 7601 cleared by the FDA?
Blood Level Detector-Model 7601 (K781330) received a 510(k) decision of Substantially Equivalent on August 31, 1978, 29 days after the submission was received.
What is the product code of K781330?
The FDA product code is FJF – Detector, Air Bubble, a Class II (moderate risk) device regulated under 21 CFR 876.5820.