WEINGARTEN TM CAPNOGRAPHIC INTUBATION STYLETTE— 510(k) K904999
Substantially EquivalentOpticon Medical, Inc.
FDA 510(k) clearance K904999 for WEINGARTEN TM CAPNOGRAPHIC INTUBATION STYLETTE, Substantially Equivalent on 1993-01-26. Applicant: Opticon Medical, Inc.. Device class: 1.
Clearance details
- Applicant
- Opticon Medical, Inc.
- Product code
- Code BSR
- Device class
- Class 1
- Regulation
- 21 CFR 868.5790
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gurnee, IL, US
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- K962361 — TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND
- K954771 — TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRACHEAL LIGHTWAND)
- K943104 — MOLLOY INTUBATING STYLETTE
- K955238 — RUSCH SCHROEDER ENDOTRACHEAL TUBE STYLE
More clearances from Opticon Medical, Inc.
view all- K033830 — OPTION-VF URINARY CATHETER WITH ADAPTOR, MODEL FVA14218; OPTION-V CONTINUOUS DRAINAGE ADAPTOR, MODEL CDA1000
- K023090 — OPTION-VF URINARY CATHETER, FV14218
- K970716 — OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE
- K930194 — HEMOSTASIS VALVE AND TUBING SET
- K895955 — LOPER CELIAC PLEXUS BLOCK CATHETER KIT
Adverse events under product code BSR
product code BSR- Death
- 2
- Other
- 1
- Total
- 3
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.