Advance Laser Flowmeter, Alf 21
FDA 510(k) K903633 · Transonic Systems, Inc.
510(k) numberK903633
Submission
- Device name
- Advance Laser Flowmeter, Alf 21
- Applicant
- Transonic Systems, Inc.
Ithaca, NY, US - Received
- August 10, 1990
- Decision date
- October 9, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DPW – Flowmeter, Blood, Cardiovascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2100
- Specialty
- Cardiovascular
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| K022963 | Transonic Syringe Warmer, Model SYR-1000MQS · Traditional | 12/04/2002SE |
| K021571 | Transonic Flow-Qc Set Model ADT1010MQS · Traditional | 08/12/2002SE |
Questions and answers
When was Advance Laser Flowmeter, Alf 21 cleared by the FDA?
Advance Laser Flowmeter, Alf 21 (K903633) received a 510(k) decision of Substantially Equivalent on October 9, 1990, 60 days after the submission was received.
What is the product code of K903633?
The FDA product code is DPW – Flowmeter, Blood, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.2100.