Examination Lamp
FDA 510(k) K922150 · Air-Shields, Inc.
510(k) numberK922150
Submission
- Device name
- Examination Lamp
- Applicant
- Air-Shields, Inc.
Hatboro, PA, US - Received
- May 7, 1992
- Decision date
- July 21, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KZF – Device, Medical Examination, Ac Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6320
- Specialty
- General Hospital
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| K934259 | Ac-Powered Medical Examination LightKZF · Traditional | Welch Allyn, Inc. | 01/28/1994SE |
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| K940975 | C450/C400 Infant IncubatorsFMZ · Traditional | 06/23/1994SE |
| K941106 | Model TI500 Isolette Infant IncubatorFPL · Traditional | 06/10/1994SE |
| K924170 | Isolette Incubator Humidity MeterFMZ · Traditional | 02/05/1993SE |
| K914864 | Models C500/C550 Isolete(R) Infant IncubatorFMZ · Traditional | 03/13/1992SE |
Questions and answers
When was Examination Lamp cleared by the FDA?
Examination Lamp (K922150) received a 510(k) decision of Substantially Equivalent on July 21, 1992, 75 days after the submission was received.
What is the product code of K922150?
The FDA product code is KZF – Device, Medical Examination, Ac Powered, a Class I (low risk) device regulated under 21 CFR 880.6320.