Slimcath (TM)
FDA 510(k) K903001 · Gynopharma, Inc.
510(k) numberK903001
Submission
- Device name
- Slimcath (TM)
- Applicant
- Gynopharma, Inc.
Princeton, NJ, US - Received
- July 9, 1990
- Decision date
- June 25, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HIT – Tester, Color Vision
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.1170
- Specialty
- Ophthalmic
Other 510(k)s with product code HIT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K875026 | Anomaloscope Plate Test - 5 [APT-5]HIT · Traditional | Lkc Technologies, Inc. | 02/05/1988SE |
| K873908 | H.R.R. Pseudoisochromatic Color Blindness Test Bk.HIT · Traditional | Richmond Products, Inc. | 12/23/1987SE |
| K873911 | Pseudo Isochromatic Color Blindness Test Book - 15HIT · Traditional | Richmond Products, Inc. | 12/02/1987SE |
| K844694 | Titmus Vision Tester IIHIT · Traditional | Titmus Optical, Inc. | 01/22/1985SE |
| K844365 | Color Vision TestersHIT · Traditional | Luneau Laboratories | 01/02/1985SE |
| K832843 | Oscar Colour Vision TesterHIT · Traditional | Keeler Instruments, Inc. | 01/04/1984SE |
| K831074 | Oscar Color Vision TesterHIT · Traditional | Carl Zeiss, Inc. | 04/28/1983SE |
| K810700 | Chromops FM-100 Color Vision TesterHIT · Traditional | Visidyne Corp. | 04/10/1981SE |
More from Visidyne Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K903002 | Probet (TM)HFF · Traditional | 04/05/1991SE |
Questions and answers
When was Slimcath (TM) cleared by the FDA?
Slimcath (TM) (K903001) received a 510(k) decision of Substantially Equivalent on June 25, 1991, 351 days after the submission was received.
What is the product code of K903001?
The FDA product code is HIT – Tester, Color Vision, a Class I (low risk) device regulated under 21 CFR 886.1170.