Floor Light
FDA 510(k) K882333 · Commercial Products & Engineering Co.
510(k) numberK882333
Submission
- Device name
- Floor Light
- Applicant
- Commercial Products & Engineering Co.
Grand Rapids, MI, US - Received
- June 6, 1988
- Decision date
- June 23, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FSS – Light, Surgical, Floor Standing
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4580
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FSS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K091246 | Iled 3 Mobile (I300M), Trulight 5500 Mobile (T500M), Trulight 5300 Mobile (T300M)FSS · Abbreviated | Trumpf Medizin Systeme GmbH + Co. KG | 09/28/2009SE |
| K003489 | Next General M20 Surgical Light; Next Generation M16 Minor Surgery Light; Next…FSS · Traditional | Medical Illumination International, Inc. | 02/02/2001SE |
| K984124 | Aesculap Xenon Light SourceFSS · Traditional | Aesculap, Inc. | 02/01/1999SE |
| K981962 | Cuda Products Corp. Model M300 (M-300) LightsourceFSS · Traditional | Cuda Products Co. | 08/18/1998SE |
| K981821 | Ves 3001/2 Dual Output Video IlluminatorFSS · Traditional | Angiolaz, Inc. | 07/29/1998SE |
| K981469 | CERMAX300 LightsourceFSS · Traditional | Cuda Products Co. | 07/09/1998SE |
| K980044 | Xenon 300MXFSS · Traditional | Perkinelmer Optoelectronics | 04/03/1998SE |
| K970886 | Hanaulux Blue 80 HospitalFSS · Traditional | Heraeus Med GmbH | 04/16/1997SE |
| K961971 | Q-5000FSS · Traditional | Stryker Endoscopy | 06/28/1996SE |
| K961074 | Lightsource or IlluminatorFSS · Traditional | Cuda Products Co. | 04/30/1996SE |
More from Cuda Products Co.
| 510(k) | Device | Decision |
|---|---|---|
| K894891 | Irrigator StandHDC · Traditional | 08/23/1989SE |
| K884542 | Sic 3999 Folding Adjustable Hospital BedFNJ · Traditional | 11/21/1988SE |
| K883463 | Hospital Bed Clothing CradleFNL · Traditional | 09/19/1988SE |
| K873545 | Portable Field Dental Operating & Treatment UnitEHZ · Traditional | 11/20/1987SE |
Questions and answers
When was Floor Light cleared by the FDA?
Floor Light (K882333) received a 510(k) decision of Substantially Equivalent on June 23, 1988, 17 days after the submission was received.
What is the product code of K882333?
The FDA product code is FSS – Light, Surgical, Floor Standing, a Class II (moderate risk) device regulated under 21 CFR 878.4580.