Space(Tm) 7500
FDA 510(k) K912071 · F.M. Wiest USA, Inc.
510(k) numberK912071
Submission
- Device name
- Space(Tm) 7500
- Applicant
- F.M. Wiest USA, Inc.
Oradell, NJ, US - Received
- May 10, 1991
- Decision date
- July 9, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- IKN – Electromyograph, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.1375
- Specialty
- Physical Medicine
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| K871181 | Arthrocombi 5003HRX · Traditional | 09/29/1987SE |
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Questions and answers
When was Space(Tm) 7500 cleared by the FDA?
Space(Tm) 7500 (K912071) received a 510(k) decision of Substantially Equivalent on July 9, 1991, 60 days after the submission was received.
What is the product code of K912071?
The FDA product code is IKN – Electromyograph, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 890.1375.