Chalgren Enterprises, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 21
- Inspections
- 4
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K982950 | FINE WIRE ELECTRODE MMODEL NUMBERS 221-14-730, 221-24-730, 221-14-550, 221-24-550 | June 22, 1999 |
| K960591 | RE-USABLE BIPOLAR CONCENTRIC NEEDLE(237-XXX-24,237-XXX-24STP, 237-XXX-24TP,237-XXX-24STP | June 13, 1996 |
| K955335 | DISPOSABLE HYPODERMIC MONOPOLAR NEEDLE RECORDING ELECTRODE | January 29, 1996 |
| K953361 | EMG DISC RECORDING ELECTRODE | January 22, 1996 |
| K953356 | EMG RECORDING RING ELECTRODE | January 22, 1996 |
| K953354 | EMG DISC RECORDING ELECTRODE | January 22, 1996 |
| K952690 | EMG DISC RECORDING ELECTRODE WITH PIN | December 6, 1995 |
| K952908 | EMG DISC RECORDING ELECTRODE WITH PIN | December 6, 1995 |
| K953886 | RE-USABLE MONOPOLAR NEEDLE | October 31, 1995 |
| K953887 | RE-USABLE CONCENTRIC NEEDLE | October 31, 1995 |
| K953219 | 22MM STAINLESS STEEL DISC ELECTRODE, WITH PIN | October 6, 1995 |
| K953220 | 32MM NICKEL PLATED DISC ELECTRODE | October 6, 1995 |
| K924277 | DISPOSABLE HYPODERMIC MONOPLAR NEEDLE RECORDING | December 7, 1994 |
| K931029 | DISPOSABLE CONCENTRIC NEEDLE ELECTRODE | August 25, 1994 |
| K924521 | DISPOSABLE CONCENTRIC NEEDLE ELECTRODE | February 12, 1993 |
| K925706 | REUSABLE FINGER CLIP RECORDING ELECTRODE | February 10, 1993 |
| K923665 | REUSABLE DUAL DISC BAR RECORDING ELECTRODES | October 5, 1992 |
| K921504 | REUSABLE DUAL DISC BAR ELECTRODES, VARIOUS MODELS | September 11, 1992 |
| K912282 | DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, VAR MODELS | March 16, 1992 |
| K912283 | DETACHABLE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE | March 16, 1992 |