The following data is part of a premarket notification filed by Pentax Precision Instrument Corp. with the FDA for Fi-10m.
Device ID | K951194 |
510k Number | K951194 |
Device Name: | FI-10M |
Classification | Laryngoscope, Non-rigid |
Applicant | PENTAX PRECISION INSTRUMENT CORP. 3117 COMMERCE PKWY. Miramar, FL 33025 |
Contact | Paul Silva |
Correspondent | Paul Silva PENTAX PRECISION INSTRUMENT CORP. 3117 COMMERCE PKWY. Miramar, FL 33025 |
Product Code | CAL |
CFR Regulation Number | 868.5530 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-03-16 |
Decision Date | 1995-04-06 |