Amer. Edwards Lab Flexiscope
FDA 510(k) K842410 · American Edwards Laboratories
510(k) numberK842410
Submission
- Device name
- Amer. Edwards Lab Flexiscope
- Applicant
- American Edwards Laboratories
Santa Ana, CA, US - Received
- June 19, 1984
- Decision date
- November 5, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HRK – Table, Instrument, Manual, Ophthalmic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4855
- Specialty
- Ophthalmic
Other 510(k)s with product code HRK
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|---|---|---|---|
| K760697 | Evans Arm and Hand RestHRK · Traditional | Alcon Laboratories | 11/02/1976SE |
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Questions and answers
When was Amer. Edwards Lab Flexiscope cleared by the FDA?
Amer. Edwards Lab Flexiscope (K842410) received a 510(k) decision of Substantially Equivalent on November 5, 1984, 139 days after the submission was received.
What is the product code of K842410?
The FDA product code is HRK – Table, Instrument, Manual, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.4855.