Baylis Pain Management Generator (PMG), Models PMG-115 (Domestic), PMG-230 (International)
FDA 510(k) K020354 · Baylis Medical Co., Inc.
510(k) numberK020354
Submission
- Device name
- Baylis Pain Management Generator (PMG), Models PMG-115 (Domestic), PMG-230 (International)
- Applicant
- Baylis Medical Co., Inc.
Mississauga, Ontario, CA - Received
- February 4, 2002
- Decision date
- May 3, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K221351 | Mechanical GuidewireDQX · Traditional | 12/19/2022SE |
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Questions and answers
When was Baylis Pain Management Generator (PMG), Models PMG-115 (Domestic), PMG-230 (International) cleared by the FDA?
Baylis Pain Management Generator (PMG), Models PMG-115 (Domestic), PMG-230 (International) (K020354) received a 510(k) decision of Substantially Equivalent on May 3, 2002, 88 days after the submission was received.
What is the product code of K020354?
The FDA product code is GXD – Generator, Lesion, Radiofrequency, a Class II (moderate risk) device regulated under 21 CFR 882.4400.