Panoptic
FDA 510(k) K121405 · Welch Allyn, Inc.
510(k) numberK121405
Submission
- Device name
- Panoptic
- Applicant
- Welch Allyn, Inc.
Skaneateles Falls, NY, US - Received
- May 10, 2012
- Decision date
- December 20, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HKI – Camera, Ophthalmic, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1120
- Specialty
- Ophthalmic
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| K171621 | Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System…MHX · Special | 06/30/2017SE |
| K142356 | Connex Spot Monitor,901058 Vital Signs Monitor CoreMWI · Traditional | 12/19/2014SE |
| K141582 | CP150 Electrocardiograph with Spirometry OptionDPS · Special | 07/11/2014SE |
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Questions and answers
When was Panoptic cleared by the FDA?
Panoptic (K121405) received a 510(k) decision of Substantially Equivalent on December 20, 2012, 224 days after the submission was received.
What is the product code of K121405?
The FDA product code is HKI – Camera, Ophthalmic, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1120.